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Care Process Model M MA O RN CT HH 22001156 D MEENNTT O A FN D D E S I G N O F M EAVNEALGOEPM Care Process Models Bipolar Disorder 2015 6 Update This care process model (CPM) was developed by Intermountain Healthcare’s Behavioral Health Clinical Program as part of a care management system for bipolar disorder. The CPM recommends screening, diagnosis, and treatment processes to improve care and outcomes for patients with bipolar disorder. Related tools — including evaluation forms, reference tools, and patient education handouts — support implementation of these recommended processes. WHAT’S INSIDE? Why Focus ON BIPOLAR DISORDER? • High prevalence. A 2005 report on National Comorbidity Survey Replication (NCS-R) data estimated that bipolar disorder affects about 5.7 million American adults, or about 2.6% of the population 18 years and older (1-year prevalence).KES1 The same study noted a lifetime prevalence of 3.9%, suggesting the chronic nature of this illness.KES2 • Inadequate detection. Estimates from surveys of people who screen positive for bipolar disorder note that clinicians misidentify their condition more than half of the time.FRY1, SUP1 Patients may visit several clinicians before being correctly diagnosed. Many suffer for a decade or more before being diagnosed and appropriately treated.BIR Misidentification leads to increased hospitalization and emergency room visits and higher healthcare costs.BIR, HIR1, PEE • Inappropriate use of antidepressants. When providers mistake bipolar depression for unipolar depression, they are likely to treat using only antidepressants.FRY1, HIR1, PEE In patients with bipolar disorder, using antidepressants alone (unopposed by mood-stabilizing medications) can induce mania, mixed states, and more severe rapid cycling varieties of this disorder.EIMA, GYU Medications with mood-stabilizing properties should be used to treat this illness. • Poor treatment adherence. Patients with bipolar disorder typically have low adherence to treatment; reported non-adherence for long-term prophylactic pharmacotherapy is about 40%.LIN Psychosocial interventions can significantly improve adherence. • Risk of death. Bipolar disorder can be a debilitating disease with a high risk of death by suicide (19%).GOO People with this disorder rate their illness as “severe” 83% of the time — much higher than they rate the severity of other mental illnesses (22%) — and have trouble functioning in many areas of life.KES2, EIMA Treatment can significantly reduce suicide rates, even in those who are more severely ill.ANG • Lost productivity. According to a recent study funded by the National Institute of Mental Health (NIMH), bipolar disorder costs the U.S. workplace $14.1 billion annually; this is nearly half as much as lost-productivity costs due to unipolar depression, although unipolar depression is more than six times as prevalent.KES3 Over the past 20 years, the World Health Organization (WHO) has consistently rated bipolar disorder among the top 10 leading causes of disability in the world.WHO UNDERSTANDING BIPOLAR DISORDER. . . . . . . . . . . . . . . . . . . . . 2 SCREENING AND DIAGNOSIS. . . . . . . 4 ALGORITHM 1: Diagnosis. . . . . . . . . . . 4 Discussion: The need for consistent screening and diagnosis. . . . . . . . . . . . 5 TREATMENT FOR ADULTS. . . . . . . . 11 ALGORITHM 2: Treatment . . . . . . . . . 11 Medications. . . . . . . . . . . . . . . . . . . . . 12 Psychosocial Therapy . . . . . . . . . . . . . 19 Electroconvulsive Therapy (ECT). . . . . 20 Care Management . . . . . . . . . . . . . . . 20 FOLLOW-UP AND MAINTENANCE. . 21 Follow-up Schedule. . . . . . . . . . . . . . . 21 Remission and Maintenance. . . . . . . . 21 Outcomes Assessment Tools. . . . . . . . 22 BIPOLAR DISORDER IN CHILDREN AND ADOLESCENTS. . . . . . . . . . . . . 24 Symptom expression. . . . . . . . . . . . . . 24 Differential diagnosis and comorbidity. . . . . . . . . . . . . . . . . . . . . 25 Treatment guidelines. . . . . . . . . . . . . . 25 PATIENT AND FAMILY EDUCATION. . 28 RESOURCES AND REFERENCES. . . . 29 GOALS /MEASUREMENTS • Improve identification of bipolar disorder by promoting and measuring use of validated screening tools such as the Mood Disorder Questionnaire (MDQ). • Improve treatment by reducing the use of unopposed antidepressants and increasing appropriate use of mood stabilizers. • Improve outcomes assessment using both symptom-specific and functional measures to determine treatment impact. Throughout this CPM, the icon at right indicates an Intermountain measure. MANAGEMENT OF BIPOL AR DISORDER DIMENSIONS OF IMPAIRMENT • Moods. Extreme mood episodes are the hallmark of this disorder. • Thoughts. Several studies detail cognitive impairment in bipolar disorder—in particular, problems with memory and executive function, attention and verbal skills.NOR • Actions. Impulsivity and excessive risk-taking are common, especially during episodes of mania. People can find themselves acting in ways that aren’t characteristic for them and don’t represent their personal values. Excessive spending, sudden travel, uncharacteristic substance abuse and sexual promiscuity are common expressions of bipolar impulsivity. MAJOR TYPES OF BIPOLAR DISORDER Bipolar I Disorder: Diagnosis requires at least one lifetime manic or mixed episode (causing significant impairment); most people with bipolar I have also had one or more episodes of major depression. Bipolar II Disorder: Diagnosis requires at least one lifetime episode of hypomania (causing less significant impairment) and at least one episode of major depression. Cyclothymia: Diagnosis requires at least 2 years (only 1 year in children and adolescents) of clinically significant distress/impairment in key areas of functioning (at work, at school, at home, with friends, etc.). This period is characterized by numerous periods where the person experiences hypomanic and depressive symptoms that fail to meet the full criteria of either hypomania or major depression. 2 MARCH 2016 UNDERSTANDING BIPOLAR DISORDER Bipolar disorder, previously called manic-depressive disorder, is a chronic biological disease, not a character defect or moral failing. People with this illness experience changes in their mood and ability to think and to function. At other times they can be completely without signs or symptoms of their illness. Depression is the most common mood in bipolar disorder but people also experience hallmark periods of euphoria and irritability. It is not unusual for these mood states to overlap and profoundly disrupt a person’s work, school, home, and social life. The risk of suicide for this illness is very high but does decrease with treatment.ANG Genetic basis The exact cause of bipolar disorder is not known. Recent studies have identified that a patient’s genetic predisposition to the disorder may derive from those genes that are involved in hormone regulation, calcium channels, secondary messenger systems, and glutamate signaling.NUR The risk of bipolar disorder increases if a parent or sibling suffers from the disorder.CRA, LIC First-degree biological relatives of someone with bipolar I disorder have a 4– 24% chance of developing bipolar I disorder, a 1 – 5% chance of developing bipolar II disorder, and a 4 – 24% chance of having unipolar depression.APA1 When one identical twin has bipolar disorder, the other twin is 7 – 8 times more likely to have it than a fraternal twin.KIE, MCG Bipolar depression versus unipolar depression Depressive symptoms are the most common in bipolar disorder. They can appear identical to those of a person with unipolar depression. More than 10% of patients with depression will go on to experience a mania or hypomania episode in the next decade. AKI Unlike unipolar depression, which is more common in women than men, bipolar I disorder is equally common in men and women.APA1 • Discriminators of unipolar versus bipolar depression: Factors suggestive of bipolar depression include an onset before the age of 25, a parent or sibling with bipolar disorder, a history of psychotic depression, postpartum depression, multiple recurrent depressive episodes, or a history of mania or hypomania induced by antidepressants. Further, bipolar depression is often associated with “atypical” symptoms including hypersomnia and hyperphagia. Depression frequently occurs with partial or complete mania symptoms such as racing thoughts, irritability, impulsivity, and psychosis.PER • Predictors of progression from unipolar to bipolar I or II depression: Among patients who have major depression and go on to develop bipolar disorder, a more acute, severe, and psychotic episode predicts bipolar I disorder (about 4% of depressives followed long term) and mood lability or temperamental instability predicts bipolar II disorder (about 9% of depressives followed long-term).AKI Bipolar spectrum Bipolar disorder and unipolar depression seem to exist at two ends of a spectrum. In the middle of the spectrum are patients with major depression and some symptoms associated with bipolar disorder (e.g., racing thoughts). These patients have more risk factors of bipolar disorder (e.g., early age of depression onset and family history) than those suffering unipolar depression without those symptoms. If these patients do not respond to standard depression treatment, clinicians should consider medications with mood stabilizing properties. Family history studies support this view of the bipolar spectrum. Patients with bipolar I disorder may have offspring with bipolar I, bipolar II, or unipolar depression, whereas patients with bipolar II disorder tend to have offspring with bipolar II or unipolar depression.BEN ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER Variety in symptom expression WHAT IS MANIA? The average age of onset of bipolar disorder is in the teen years to early 20s. The first episode can be either a depressive or manic episode. Transitioning from a manic/hypomanic episode to a depressive episode or from a depressive episode to a manic/hypomanic is considered one “cycle” of bipolar disorder. The episodes in each cycle can vary from mild to severe in intensity. They can be interspersed by long periods of euthymic mood or be followed immediately by another mood cycle. Disability in functioning is usually related to how frequently people cycle and how severe their symptoms are during their cycle. KES2 • Proportion of time spent in various mood states. People with bipolar disorder suffer reoccurring mood symptoms throughout their life. One study tracked patients’ moods weekly for over a decade for the two major types of the illness (bipolar I disorder and bipolar II disorder). In this study, most of the time symptomatic was spent depressed and a minority of time was spent either manic or hypomanic.JUD1,JUD2 These results are shown below: Cycling/Mixed Manic/Hypomanic (6%) (1%) Cycling/Mixed (2%) Manic/Hypomanic (9%) Asymptomatic Asymptomatic Depressed (53%) Depressed (32%) Bipolar I 146 patients followed 12.8 years (46%) (50%) Bipolar II 86 patients followed 13.4 years • Severity of symptoms. Over the long-term course, the majority of symptoms are subsyndromal or not severe enough to diagnose as major depression or as overt mania. Nevertheless, subsyndromal depressive symptoms can be significantly disabling. Hypomanic episodes are often rated by patients as causing no disability (and some feel it to be a state of superior functioning). Severe manic symptoms are as disabling as severe depressive symptoms. • Combinations of symptoms. It is common to have symptoms of mania/ hypomania and depression at the same time. An estimated 40% of manic episodes and more than half of all hypomanic episodes are associated with significant depressive symptoms.SUP2 Some people with bipolar disorder experience mixed states — episodes in which they have symptoms that meet criteria for both mania and depression nearly every day for a 1-week period or longer. Mixed episodes are common and can be very severe. They are also associated with less frequent remissions, poorer response to mood stabilizers, increased suicidal ideation/behavior, and more comorbidities (including substance abuse). Use of antidepressants is also associated with increased incidence of mixed episodes.HIR1, GOL1, PRI, SHA • Frequency of episodes. Cycling varies from an average of 1 cycle every 3 years to the severe variation called rapid cycling. Rapid cycling is when people cycle between mood episodes four or more times a year. This variety can be either bipolar I or bipolar II. The typical patient is bipolar II and female. In this variant, there appears to be a continuous distribution from limited mood cycling to the extreme of intraday (ultraradian) cycling. This form of the illness may be less sensitive to the effects of lithium carbonate. Factors associated with rapid cycling include the following:GOL1, Mania is defined as a mental state characterized by rapid thoughts, irritable/ euphoric mood, increased activity, talkativeness, and/or impaired judgment. Manic or hypomanic patients exhibit these types of symptoms: • Activity or stimulation: Symptoms are similar to those experienced when one takes excessive doses of stimulant medications, such as euphoria and irritability. Actions and feelings are also stimulated: a manic patient may need less sleep, have increased speed of thoughts, speak faster or with pressure, have increased focus on activities, and be overtly agitated. Increased activity can range from doing a routine task excessively, such as doing housework all night long, to becoming involved in uncharacteristic activities, such as planning multiple risky business ventures. • Intensity: Mania symptoms are experienced with heightened intensity. They may be intensely pleasurable or intensely dysphoric. • Impaired judgment and thinking: Behavior and actions are often impulsive and pleasure-seeking. When manic, patients can participate in uncharacteristic overspending, promiscuity, substance abuse, or other impulsive behavior. Judgment may be affected by perceptual disturbances such as auditory hallucinations, thought problems such as paranoia, flight of ideas (ideas that change so rapidly that they are confusing), or false beliefs (e.g., that one is more powerful, famous, or successful than in reality). Over half of patients who have bipolar disorder experience psychotic symptoms at some time during their illness.GOO PRI, SHA, HIR2, SCHN –– Female gender and early life trauma (more strongly associated with cycling between mood states more than once a month) –– Antidepressant use –– Genetic susceptibility (higher prevalence of the double short allele of the serotonin transporter protein) –– Clinical or subclinical hypothyroidism The variables noted above should be considered when diagnosing bipolar disorder — and when treating it. Medication(s) can alter the expression of the disorder. ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 3 MANAGEMENT OF BIPOL AR DISORDER MARCH 2016 SCREENING AND DIAGNOSIS ALGORITHM NOTES (a) PHQ-2 Scoring The PHQ-2 consists of the first two questions in the PHQ-9 (see page 5) used as a first step in screening patents for depression. Scoring for each question is indicated below: ALGORITHM 1: DIAGNOSIS TABLE 1. PHQ-2 Scoring ADMINISTER and SCORE the first two questions of the Patient Health Questionnaire (PHQ-2) (a) Score* based on patient response to each item below: Over the past 2 weeks, how often have you been bothered by any of the following problems? Item Positive? 0–3 Feeling down, depressed or hopeless 0–3 Total Score (Positive = ≥ 3) 0–6 The PHQ-9 (see page 5) uses both a symptom score and a severity score. Scoring guidance for each type is indicated below: Positive? Scoring Guidelines Symptom Score ≥ 5 = Administer MDQ (see page xx) < 5 = Usual care; see Depression cpm. Severity Score Suicidal Ideation *NOTE: the score from the Question 9 Positive?* PHQ-9 does not override clinical judgment. no TREAT per Depression CPM • Question 2: Positive (yes) response • Question 4: “moderate” or “serious” response 4 Prevention CPM) no Positive? Positive? yes ASSESS for comorbidities (see page 8) (c) MDQ Scoring • Question 1: 7 / 13 positive (yes) responses ASSESS suicide risk and DETERMINE associated treatment (see page 5 and Suicide •• INTERVIEW patient to confirm specific DSM-5 diagnostic criteria. •• USE SADFIGS mnemonic to aid diagnosis (see page 7). •• RATE severity of illness with CGI Scale (see page 22). If “yes” to question #9, assess suicide risk. For a positive screen, all three of the following criteria must be met: yes PROVIDE usual care ADMINISTER and SCORE(c) the Mood Disorder Questionnaire (MDQ) (see page 6 (c) ≥ 9 = Administer MDQ (see page xx) < 9 = Usual care; see Depression cpm. Score the MDQ according to the criteria below and guidance in the Scoring and Evaluating Adult MHI Forms CPM. no yes TABLE 2. PHQ-9 Scoring Measure PROVIDE usual care ADMINISTER and SCORE the Patient Health Questionnaire (PHQ-9) to identify and diagnose major depression (see page 5) (b) *Score based on the following: 0 = Not at all; 1 = Several Days; 2 = > Half the Days; 3 = Nearly Every Day (b) PHQ-9 Scoring no yes Score Range* Little interest or pleasure in doing things Patient appointment with primary care provider Patient appointment with mental health specialist Mental health specialist Primary care provider •• REFER to a mental health specialist if patient has TREAT per algorithm on page 10 unmanageable conditions or behaviors such as significant comorbidities, psychotic tendencies, suicidal ideation/behavior, violence, or treatment failures. •• START treatment (using a medication with mood-stabilizing properties per algorithm on page 11) while awaiting mental health referral or consultation. •• DO NOT USE UNOPPOSED ANTIDEPRESSANTS. ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER Discussion: The need for consistent screening and diagnosis Patients with bipolar disorder may see multiple healthcare providers for as many as 10 years or more before they receive the correct diagnosis. This is due in part to these factors: • People with bipolar disorder seek treatment more often when depressed, and thus they are often treated for unipolar depression. • Bipolar disorder is often comorbid with substance abuse and anxiety disorders, which can mask and complicate symptoms. Thus, assessing for comorbidities is a critical part of the screening process (see pages 9 – 10). • There is often no consistent process for screening and diagnosis in various care settings. Primary care providers (PCPs) are generally the first care providers who see a patient with bipolar disorder. Unfortunately, since patients often present with symptoms of depression, bipolar disorder is often misdiagnosed as unipolar depression and treated inappropriately with an unopposed antidepressant, which can make the illness worse. Unopposed antidepressants may induce mania and mixed bipolar states, mood instability, and rapid cycling. Patients eventually diagnosed with bipolar disorder often experience multiple failed antidepressant trials or the onset or worsening of agitation and anxiety while on antidepressants.FRY1, SUP1, BIR, HIR1, PEE You can download the PHQ-9 at: https://m.intermountain.net/forms/ Pages/Details.aspx?isForm=true&ncid=52 1377846&title=MHI PHQ-9 Patient Health Questionnaire To improve early identification and treatment of bipolar disorder, this CPM recommends a consistent process for screening and diagnosis in all treatment settings. This includes use of validated screening tools such as the Patient Health Questionnaire (PHQ-9) for depression and suicidal ideation and behavior (content appears at right) and the Mood Disorder Questionnaire (MDQ) for mania (content appears on page 6).HIR3 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 5 MANAGEMENT OF BIPOL AR DISORDER MARCH 2016 Suicide assessment As shown in the algorithm on the previous page, an assessment of suicide risk should be done for every patient who responds positively to question 9 on the PHQ-9 or who has experienced suicidal ideation (thoughts of engaging in suicidal behavior). Although suicide is a low-probability event, bipolar disorder is one of the most common psychiatric disorders associated with suicide.PAL, SAR Patients with bipolar disorder have a high rate of lifetime suicide completion (about 19%).GOO Intermountain uses the Columbia-Suicide Severity Rating Scale (C-SSRS) to standardize assessment of suicidal ideation and behavior, determine levels of risk, and make clinical decisions about care. The Suicide Prevention CPM details the C-SSRS versions used and suggested treatment approaches in each care setting. The table below (from page 3 of the Suicide Prevention CPM) provides an overview of risk level (based on a positive response to each C-SSRS Quick Screen question and recommended actions to take in each setting based on patient responses. See the Suicide Prevention CPM for detailed steps for asking these questions. TABLE 3: Patient safety measures and response protocols based on Quick Screen responses C-SSRS Quick Screen questions (in the last month) Question “Yes” Level of risk indicates LOW Action if patient response “Yes” Outpatient clinic (non-BH) ED at triage •• Consider referral to MHI or BH provider •• Consider patient education •• Consider referral to MHI or BH provider at discharge from ED •• Consider patient education •• Continue with plan of care For identified BH patients BH unit 1. Have you wished you were dead or wished you could go to sleep and not wake up? Wish to be dead 2. Have you actually had any thoughts of killing yourself? Nonspecific thoughts 3. Have you been thinking about how you might kill yourself? Thoughts MODERATE with method (without specific plan or intent to act) •• Assess risk factors and either facilitate evaluation for inpatient admission or complete Safety Plan with follow-up in 24 – 48 hours •• Educate patient •• Initiate nursing interventions (e.g., secure belongings) •• Order crisis worker evaluation •• Psychiatric consult recommended •• Continue with plan of care •• Initiate nursing interventions 4. Have you had these thoughts and had some intention of acting on them? Intent (without plan) HIGH •• Facilitate immediate evaluation •• Educate the patient •• Initiate nursing interventions •• Order PSA until crisis worker evaluation complete •• Notify ED physician •• Order crisis worker evaluation •• Psychiatric consult highly recommended •• Notify charge nurse/shift coordinator •• Notify attending physician •• Assess need for 1:1 •• Initiate nursing interventions •• Administer C-SSRS Lifetime/ Recent Assessment (Adult/Adolescent or Pediatric) >1 year ago: LOW •• Consider referral to MHI or BH provider •• Consider patient education 1 – 12 months ago: MODERATE •• Assess risk factors and refer to MHI or BH provider •• Educate patient 5. Have you started Intent to work out or with plan worked out the details of how to kill yourself? Do you intend to carry out this plan? 6. Have you ever done anything, started to do anything, or prepared to do anything to end your life? Behavior Past 4 weeks, during •• Facilitate immediate current inpatient stay, evaluation for since last assessment: inpatient care HIGH •• Educate patient 6 Inpatient care •• Continue with plan of care •• Notify charge nurse/shift coordinator •• Notify attending physician •• Assess need for 1:1 •• Order crisis worker evaluation •• Psychiatric consult recommended •• Assess risk factors and consider referral to MHI or BH provider •• Initiate nursing interventions •• Order crisis worker evaluation •• Initiate nursing interventions •• Order PSA •• Psychiatric consult highly recommended •• Notify charge nurse/shift coordinator •• Notify attending physician •• Assess need for 1:1 •• Initiate nursing interventions •• Notify charge nurse/shift coordinator •• Notify attending physician •• Assess need for 1:1 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER Mood Disorder Questionnaire (MDQ) WHEN TO SCREEN The Mood Disorder Questionnaire (MDQ) is a tool that screens specifically for bipolar disorder. It is NOT a diagnostic instrument. Used alone in a population with low rates of bipolar disorder (e.g., in primary care settings), it will produce significant false positive results. Therefore, screening an enriched population, such as those who meet diagnostic criteria for depression and/or have failed an antidepressant trial, or Mental Health Adult those for whom the clinician intuits bipolar disorder, is likely to correctly identify the most patients. Mood (Note that patients who have a negative result using the MDQ are Disorder Questionnaire (MDQ) (page 1 of 1) unlikely to have bipolar disorder.) Content of the MDQ form appears below; see the Today’s Date: Patient’s Name: Date of Birth: notes at right for tips on using and interpreting the tool. • In primary care settings: Primary care Integration providers should screen all new patients for depression with the PHQ; patients who screen positive for depression should be further screened with the MDQ. • In mental health provider settings: Mental health specialists should screen all new patients with the MDQ. INTERPRETING RESULTS YES NO … you felt so good or so hyper that other people thought you were not your normal self, or you were so hyper that you got into trouble? For a positive screening, questions 1 and 2 must both be positive: … you were so irritable that you shouted at people or started fights or arguments? • For question 1, a positive result is 7 or … you felt much more self-confident than usual? … you got much less sleep than usual and found you didn’t really miss it? … you were much more talkative or spoke much faster than usual? … thoughts raced through your head or you couldn’t slow your mind down? … you were so easily distracted by things around you that you had trouble concentrating or staying on track? … you had much more energy than usual? … you were much more active or did many more things than usual? … you were much more social or outgoing than usual; for example, you telephoned friends in the middle of the night? … you were much more interested in sex than usual? … you did things that were unusual for you or that other people might have thought were excessive, foolish, or risky? … spending money got you or your family into trouble? 1 Has there ever been a period of time when you were not your usual self and… 2 If you checked YES to more than one of the above, have several of these ever happened during the same period of time? 3 During the period of time indicated above, do you think any of these symptoms were brought on by prescription or other drugs? 4 How much of a problem did any of these cause you — like being unable to work; having family, money, or legal troubles; or getting into arguments or fights? no problem minor problem moderate problem American Psychiatric Association. / 13 *50402* When a Intermountain patientHealthcare. screens for bipolar disorder using the MDQ: ©2004–2014 All rightspositive reserved. MHI Pack 50402 Patient and Provider Publications 801-442-2963 MHI019 - 10/14 • For question 2, a positive result is “yes.” • Question 3 measures potential for medication-induced symptoms. • Question 4 measures impairment. A response of “moderate” or serious” suggests bipolar I disorder, whereas a response of “minor” or “no problem” suggests bipolar II disorder. (See the following page for more detail on distinguishing these 2 bipolar variants.) IMPROVING SENSITIVITY Adding the following 2 sub-questions to question 1 of the MDQ can improve the sensitivity of the MDQ screening by as much as 10% (as suggested by 2007 Intermountain Healthcare data): • Have any close family members (parents, siblings, children) ever been diagnosed with bipolar disorder or manic depression? serious problem For Office Use Only: What next? Reprinted with permission from the American Journal of Psychiatry, (Copyright 2000). more of the 13 sub-questions answered “yes.” • Interview the patient to determine if the patient has had at least one lifetime episode of depression and one lifetime episode of mania or hypomania. • Did you have mood problems before the age of 25? When these two questions are added to the 13 items in section 1, patients who answer “yes” to <6 of the 15 questions are very unlikely to have bipolar disorder. • Use DSM-5 diagnostic criteria to determine and confirm a diagnosis (see page 8). ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 7 MANAGEMENT OF BIPOL AR DISORDER A MNEMONIC TO AID DIAGNOSIS: SADFIGS For confirmation of a lifetime episode of mania or hypomania — and a bipolar disorder diagnosis — a patient’s symptoms must meet these criteria: MARCH 2016 Diagnostic criteria The table below provides an overview of key diagnostic criteria for bipolar 1 disorder, bipolar II disorder, and cyclothymic disorder — the most prevalent bipolar disorder diagnoses. TABLE 4: Overview of Major1 Bipolar DiagnosesAPA1 Episode Type(s) • A consistently elevated, irritable, or A Agitation or increased focused activity D Distractibility F Flight of ideas or racing thoughts I Impulsivity G Grandiosity S Speech, rapid or pressured (ICD-10: FS31.81) Sleep, less need (ICD-10: FS34.0) S Bipolar I (see box at bottom of page for ICD-10 codes) following SADFIGS symptoms. If irritable mood, at least four of the following SADFIGS symptoms: Bipolar II • If elevated mood, at least three of the Severity3 Manic Lifetime 1 week; almost daily; >50% of each day Impacts all key areas of functioning, includes psychotic features, or necessitates hospitalization Hypomanic AND major depressive Lifetime 4 days; almost daily; >50% of each day Functioning is not seen as usual for patient by others in key areas; no psychotic features; no hospitalization needed Past 2 years (1 year if child or adolescent); 50% of overall time; symptom free < 2 months within time frame Impacts key areas of functioning and causes considerable distress (Required)1 Cyclothymia expansive mood lasting at least 1 week (or any duration if hospitalization is required) for mania and at least 4 days for hypomania. Context1 Duration2 Symptoms related Lifetime or to hypomanic AND past 2 years? major depressive BUT not meeting full criteria for either episode as defined by DSM-5 1. For information related to other bipolar diagnoses (substance/medication-induced bipolar and related disorders, bipolar and related disorders due to another medical condition, and other specified bipolar and related disorders), see Diagnostic and Statistical Manual of Mental Disorders — Fifth Edition.APA1 2. Context: time frame in which symptomatic episode must have occurred (e.g., lifetime, past 2 years, etc.) 3. Duration: specific number of days that symptoms occurred; symptoms last for a specified time and frequency during those days 4. Severity: symptoms are severe enough to cause patients considerable distress and impact their daily functioning in key areas of their lives ICD-10 CODING FOR BIPOLAR I Diagnostic coding for bipolar I is typically based on current or most recent episode and severity. General ranges appear in this box. For more detailed coding instructions, refer to ICD10data.com. F31.6 Bipolar disorder, current episode mixed (specify severity and presence of psychotic features) F31.0 Bipolar disorder, current episode hypomanic F31.7_ Bipolar disorder, currently in remission (specify full or partial remission and type of most recent episode) F31.1_ Bipolar disorder, current episode manic without psychotic features (specify severity) F31.8 Other bipolar disorders (F31.81 Bipolar II disorders; F31.89 other bipolar disorder) F31.2 Bipolar disorder, current episode manic severe with psychotic features F31.9 Bipolar disorder, unspecified F31.3_ Bipolar disorder, current episode depressed mild or moderate severity (specify severity) NOTE: ICD-10 codes do not correspond exactly to DSM-5 codes and explanations. Intermountain‑employed providers F31.4 Bipolar disorder, current episode depressed, severe without psychotic features can access an online version of the DSM- through the eResources page on IntermountainPhysician.org or Intermountain.net. F31.5 Bipolar disorder, current episode depressed, severe with psychotic features 8 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER Comorbidities OTHER COMORBIDITIES/ DIFFERENTIAL DIAGNOSES Those with bipolar disorder typically suffer from at least one comorbid medical or psychiatric disorder (some studies indicate a large number of patients having at least three chronic medical conditions) as well as having higher lifestyle risk factors that occur at a younger age.VA These comorbidities can confuse and confound diagnosis and treatment and also make the disorder more severe and difficult to treat. Comorbidities are associated with increased emergency room visits and more hospitalizations.NOR, GOL2 The most common mental health comorbidities are described below; medical comorbidities are discussed on page 10. • Attention deficit hyperactivity disorder • Disruptive mood dysregulation disorder • Eating disorders • Intermittent explosive disorder • Major depressive disorder Mental Health Comorbidities • Personality disorders including borderline personality disorder The most common comorbid mental health conditions are anxiety disorders and substance use disorder. When co-occurring major psychiatric illnesses and/or significant suicidal ideation/behaviors or homicidality are present, clinical guidelines emphasize the importance of referring these patients to specialty care (see also suicide assessment information on page 6).VA For complete differential diagnosis information on these disorders, see the Diagnostic and Statistical Manual of Mental Disorders — Fifth Edition.APA1 Anxiety disorders. Anxiety disorders are the most common mental health comorbidities in patients with bipolar disorder — nearly 75% of patients have comorbid bipolar disorder and some type of anxiety disorder.KES4 Common features of anxiety include panic attacks, fears, and worries. Somatic symptoms include poor concentration, agitation, muscle tension, headache, and perspiration. It may be difficult to differentiate agitation caused by mania from anxiety caused by a comorbid anxiety disorder. Anxiety symptoms may be difficult to separate from symptoms of agitation while a patient is experiencing mania. What to do: Treat the bipolar disorder first; treatment may take care of anxiety symptoms. • For men, ≥5 standard drinks* a day For women, ≥4 standard drinks* a day Daily or Almost Daily • Weekly Alcohol: Monthly In the past year, how often have you used the following? Once or Twice Intermountain-Modified National Institute on Drug Abuse (NIDA) Quick Screen Never Substance use disorder. Substance use disorder is the second most common comorbid diagnosis in bipolar disorder.KES4, WEI More than half of patients with bipolar disorder will have a substance use diagnosis in their lifetime. Substance use disorder includes alcoholism, tobacco use, prescription drug abuse, and “street drug” abuse. Alcoholism is the most common of the substance use comorbidities.WEI The incidence of alcoholism in those with bipolar disorder is 3 times higher for men and 7 times higher for women.FRY2 What to do: Use the NIDA Quick Screen Tobacco products (including e-cigarettes) (download the full-size version of this tool here: Intermountain-Modified NIDA Quick Screen to screen for substance use disorder. If identified, aggressively treat the substance use disorder concurrently with bipolar disorder based on the Substance Use Disorder CPM. Successful treatment of bipolar disorder is unlikely with ongoing substance-use problems. Avoid lithium as a primary mood stabilizer in these patients, and use habit-forming sedatives with caution. Prescription medications for non-medical reasons Prescription medications in amounts greater than prescribed, for reasons other than prescribed, or that weren’t prescribed to you Illegal drugs (illicit, street drugs) ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. Beer or cooler (5% alcohol): 12 ounces Malt liquor (7% alcohol): 8–9 ounces • Table wine (12% alcohol): 5 ounces • 80-proof spirits (hard liquor) (40% alcohol): 1.5 ounces • *Definition of a “standard drink:” • 9 MANAGEMENT OF BIPOL AR DISORDER THE IMPORTANCE OF INTERDISCIPLINARY COLLABORATION For patients with bipolar disorder and other medical conditions, early and regular screening for comorbidities and careful medication management is crucial. For example, corticosteroids used to treat asthma and inflammatory disease and stimulants can be associated with secondary mania. Taking diuretics and angiotensincoverting enzyme inhibitors with lithium in patients with kidney disease or hypertension may complicate bipolar disorder treatment. Careful consideration of medications that tend to promote weight gain is also important. Referrals to a registered dietitian nutritionist (RDA) can be helpful in dealing with dietary intake and glycemic load. MARCH 2016 Medical comorbidities Medical problems can not only cause mood episodes but can exacerbate the course of bipolar disorder and complicate treatment in terms of greater illness severity, reduced recovery, and increased or premature mortality. These comorbidities often accentuate psychological stressors related to employment and disability reimbursement and increase healthcare utilization.VA Major medical comorbidities in patients with bipolar disorder include cardiovascular disease, autoimmune diseases, cancer, and metabolic disorders. Of these, metabolic disorders (especially diabetes and obesity) offer significant challenges, in part due to the weight-gain side effects of many medications used to treat bipolar disorder. In addition, there are significant challenges of care associated with comorbid diabetes, including:VA • Almost double the overall health care costs for bipolar patients who have diabetes • Greater impairment in both physical and mental health • Lower quality of life • Less satisfaction with health According to recent research, there is a bi-directional relationship between comorbid metabolic disorders and bipolar disorder because those with bipolar disorder tend to take in more calories with a higher glycemic load and are significantly more sedentary than the general population.MAN In addition, a 2012 population-based study of 800,000 people indicated that those with untreated type 2 diabetes had a significantly increased risk of developing bipolar disorder and that treating diabetes may prevent bipolar onset.MAN Other medical comorbidities can include thyroid dysfunction, migraines, and cardiovascular disease. Considerations include: • Thyroid dysfunction. Hypothyroidism is associated with rapid cycling and difficult-to-treat depression, and hyperthyroidism can produce agitation and anxiety that can make the identification of mania more difficult. • Other medical comorbidities lead to additional disability and mortality for bipolar patients. Note that compared to people without bipolar disorder:CAS, ELM, MAH, SCHI, WEE –– Incidence of migraines is 5 times higher. –– Incidence of cardiovascular disease is 1.9 times higher. What to do: Assessment for bipolar disorder must include assessment for the medical the conditions above. Patients should be treated concurrently — and extra monitoring may be necessary. Many medications used to treat this illness can aggravate cardiovascular risk factors (cardiovascular disease is the leading cause of death in patients with bipolar disorder). 10 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER TREATMENT FOR ADULTS Patients with bipolar disorder have better outcomes with aggressive, multimodal treatment that includes appropriate medication, patient/family education, psychotherapy, and (when available) care management. The target for treatment is FULL REMISSION. Patients who achieve remission will have lower rates of relapse. To assess progress toward this goal, providers should have a consistent method — such as the CGI scores described on page 18 — to assess response to treatment. Note that because of limited quality studies comparing treatment outcomes, the guidelines presented in this CPM are reasonably broad and focus primarily on bipolar I disorder. There is little quality evidence to support specific treatments for bipolar II disorder, and no published research for bipolar not otherwise specified (NOS). The algorithm below and the discussion and tables that follow present a recommended approach to treatment based on the best available evidence, along with expert opinion from clinical practice. ALGORITHM 2: TREATMENT Patient diagnosed with bipolar I or bipolar II *Note: In emergency situations with acute symptoms, rapid titration and more than one medication may be necessary to reduce time to response. However, lamotrigine should never be rapidly titrated due to increased risk of allergic rash. START monotherapy with a medication with mood stabilizing properties* START with a mood stabilizer with “A” quality data for treatment of the appropriate pole. See the medication tables on pages 13 – 16 for details. Bipolar depression: START with ONE of these: • Quetiapine • Lamotrigine • Lurasidone • Olanzapine + fluoxetine • PROVIDE patient/family education (see pages 27 – 28) for psychotherapy • CONSIDER care management Mania/mixed mania: • REFER START with: • Lithium carbonate (mania) OR Divalproex sodium (mania/mixed) OR • An atypical antipsychotic: • Aripiprazole • Ziprasidone • Olanzapine • Lurasidone • Quetiapine • Asenapine • Risperidone FOLLOW UP in 1 – 2 weeks as indicated by acuity and severity Adequate response? ADD a second mood stabilizer. no yes (Somewhat or much improved CGI global improvement score 1 – 3) For moderate to severe symptoms: • COMBINE lithium and valproic acid with each other OR with an atypical antipsychotic • CONSIDER the combination of olanzapine and fluoxetine (Symbyax), which is FDA approved for bipolar 1 depression. FOLLOW UP in 4 weeks until remission. At every follow-up visit: • EVALUATE adherence • ASSESS clinical response and side effects at current dose • USE outcome measures to assess progress (see page 22) • ASSESS educational needs • ASSESS therapeutic alliance (see page 21) • ASSESS for substance abuse (see page 9) Improved? Much improved CGI score 1 – 2 • CONTINUE at present dosage(s). • FOLLOW UP every 4 weeks until remission (CGI severity score 1 – 2). • When in remission, FOLLOW UP at least every 6 months to monitor symptoms, lab values, and functional outcomes. Somewhat improved CGI score 3 • RAISE dose of mood stabilizer as tolerated. OR • ADD a second mood stabilizer focused on specific symptoms No improvement or worsening CGI score 4 – 7 • RAISE dose as tolerated; if at maximum dose, change to a different primary mood stabilizer. OR • ADD a second mood stabilizer focused on specific symptoms • CONSIDER consultation/referral to a mental health specialist TARGET: FULL REMISSION (CGI severity score 1 – 2) ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 11 MANAGEMENT OF BIPOL AR DISORDER THE 3 Ms OF MEDICATION MANAGEMENT FOR BIPOLAR DISORDER Mood stabilizers In general, people with bipolar disorder should be treated with mood stabilizers for extended periods of time (years). Other medications are added when necessary, typically for shorter periods, to treat episodes of mania or depression that break through despite the mood stabilizer. NOTE: if antidepressants are prescribed, mood-stabilizers must be continued as well. Multiple medications Studies indicate that most patients will need more than one medication to achieve remission.GIT Expert consensus guidelines suggest adding a second medication after 1–2 weeks of inadequate response to one medication or for moderate-tosevere symptoms.APA2, KEC Combining lithium or divalproex sodium with an atypical antipsychotic can be effective.MOL However, mixing atypical antipsychotics has no clinical research to support its efficacy and may increase the impact of shared side effects. Monitoring Because using multiple medications increases side effects, complicates treatment, and worsens patient compliance, monitor patients carefully for these problems. See the treatment algorithm on page 10 and the medication table at right for specific considerations. In addition, monitoring is especially warranted for patients taking antidepressants due to the risk of manic switch. ADJUNCT MEDICATIONS Benzodiazepines such as alprazolam, clonazepam, and lorazepam are often useful for treating insomnia, anxiety, and agitation. Anticholinergics and beta-blockers are used for patients at risk for or currently experiencing medication-induced extrapyramidal symptoms (EPS) such as pseudo-Parkinsons, akathisia and acute dystonia. Thyroid supplements may be necessary for some patients on lithium carbonate since it can interfere with thyroid functioning. 12 MARCH 2016 Medications Because bipolar disorder is a recurrent and chronic illness, long-term pharmacotherapy is almost always indicated. Optimizing medication for people with bipolar may require some trial-and-error to balance medication effectiveness with the associated side-effect burden. Overall, this process should be driven by the best scientific evidence possible — starting with FDA approved treatments or treatments that have shown positive effects in large controlled trials. Medication recommendations (detailed on pages 13 – 18) are based on the strength of evidence derived from review of literature, product package inserts, and experience from clinical practice. Mood stabilizers Medications with mood-stabilizing properties are the mainstay of treatment for bipolar disorder. Mood stabilization happens when a medication effectively treats at least one pole of bipolar disorder without worsening the opposite pole. Medications with mood-stabilizing properties are a heterogeneous group that can be categorized by drug class and by whether they best treat mania, depressive symptoms, or both. The group includes the following: • Anticonvulsants, including carbamazepine, divalproex, lamotrigine, and oxcarbazepine • Lithium carbonate • Atypical antipsychotics, including aripiprazole, asenapine, lurasidone, olanzapine, quetiapine, risperidone, and ziprasidone Providers should choose a mood-stabilizing medication based on whether the patient presents with depression, mania, or a mixed state — and on the severity of symptoms. Because of significant side effects, careful monitoring is important for patients taking mood stabilizers. Tables 6A and 6B on page 16 detail recommended monitoring for each medication/class. Preference should be given to a mood stabilizer intended for maintenance; some medications are better at preventing mania and some are better at preventing depressive relapse (see information on use in table 5 on pages 13 – 15). Antidepressants Although bipolar disorder is mostly a depressive illness, evidence indicates that antidepressant monotherapy is no more effective than mood stabilizers at treating bipolar depression — and lacks maintenance properties.GHA, WHE, SAC In fact, unopposed antidepressants may actually induce or worsen mania, promote rapid cycling between poles, and destabilize the course of bipolar treatment.EIMA, GYU, HSIN Despite this, antidepressants remain the most widely prescribed medications for the treatment of bipolar depression. Antidepressants should not be used without mood-stabilizing medications to minimize a patient’s risk of switching to mania or rapid cycling, which further increases the risk of future switches. Bipolar II disorder (characterized by at least 1 depressive and 1 hypomanic episode over the course of a lifetime) lacks clear treatment guidelines; however, interventions are critical for these patients for treatment and prevention, especially due to suicide risk. Internationally, patients with bipolar II experience similarly high rates of suicidal ideation (50.6%) and attempted suicide (20.8%) as those with bipolar I disorder.HSIN A review of recent, evidence-based treatment strategies for bipolar II depression and bipolar depression with mixed features strongly recommends treatment with quetiapine for acute therapy and lithium for maintenance therapy.HSIN ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 TABLE 5. Medications Class MANAGEMENT OF BIPOL AR DISORDER used to treat bipolar disorderKUP1,2; LEC1,2; LEX; POST; STA1,2; STO1,2 Medication Use (strength (common brands) of evidence1) carbamazepine (Carbatrol, Tegretol) Mania (A), but due to significant side effects, use only after trying all other meds with (A) strength evidence Bipolar depression (C) Maintenance (B) FDA-approved valproate (or divalproex sodium) (Depakote, Depakote ER) Anticonvulsants NOTE: divalproex is referred to as valproate throughout this CPM. lamotrigine (Lamictal) Dosage guidelines2 Initiate: at 200 mg/twice daily; then increase by 200 mg/day at weekly intervals Range: 400 – 1600 mg/day Target: serum level 4 – 12 mcg/mL 1 $$ – $$$ Initiate: at 25 mg/kg/day in divided doses Bipolar depression, maintenance (A) Mania (D); no acute efficacy for mania Initiate: at 25 mg once daily •• Auto-inducer: Monitor and adjust serum levels due to liver induction. •• Agranulocytosis, aplastic anemia, thrombocytopenia, hepatic failure and toxic dermal eruptions can rarely occur. 1 $$ – $$$ •• Common side effects include nausea, diarrhea, thrombocytopenia and moderate weight gain. Titrate: rapidly to desired clinical effect •• Dose range presented is for valproate (divalproex). May be given as an extended release formula once daily instead; add 8 – 20% to total daily dose (usual 250 – 500 mg). Range: 750 – 3,000 mg/day •• Agranulocytosis, aplastic anemia, hyperammonemia, hepatic failure and toxic dermal eruptions can rarely occur. Target: serum level 50 – 125 mcg/mL (mid to upper range generally required) Titrate: per set schedule: •• 25 mg once daily x 2 wks 1 $ – $$ •• If taking with divalproex, halve titration doses; if taking with carbamazepine, double titration doses (but no more than 100 mg/day increase). •• May provoke toxic dermal eruptions (Stevens-Johnson Syndrome, toxic epidermal necrolysis), but markedly reduced risk when titrated as directed; patient should seek medical attention immediately if a rash appears. •• Common side effects include nausea and rash; if continuing therapy despite rash, reduce dose and titrate more slowly once rash resolves. •• Further titrations <100 mg per day at weekly intervals Initiate: at 300 mg twice daily; increase by 600 mg/day at weekly intervals Range: 600 – 2400 mg/day divided Usual Target: 1,200 mg/day •• Do not titrate more rapidly than recommended dosing schedule due to increased risk of potentially fatal rash. •• Dose adjustment is needed if concomitant enzyme-inducing antiepileptic medication or valproic acid is discontinued. •• 50 mg once daily x 2 wks •• 200 mg once daily thereafter Mania, bipolar depression, and maintenance (C) Not FDAapproved •• Strong inducer of CYP1A2, CYP2B6, CYP2C19, CYP2C8, CYP2C9, and CYP3A4. •• Common side effects include dizziness, headache, nausea, moderate weight gain, sedation and ataxia. •• 100 mg once daily x 1 wk oxcarbazepine (Trileptal) Side effects and other comments (see page 16 for monitoring guidelines) •• Prior to therapy, screen with HLA-B*1502 genotype. Mania and maintenance (A) Bipolar depression (B) (Better at preventing manic episodes than depressive episodes) FDA-approved (for treatment of mania) FDA-approved Tier/ Cost 3 •• Estrogen-containing oral contraceptives may decrease lamotrigine levels by 50%. 1 •• Strong inducer of CYP3A4. $$ •• Common side effects include dizziness, headache, nausea and sedation. •• Agranulocytosis, aplastic anemia, hepatic failure, hyponatremia and toxic dermal eruptions can rarely occur. •• May reduce effectiveness of contraceptives •• Prior to therapy, screen for HLA-B*1502 genotype. Strength of evidence key: (A) = Based on data from large controlled trials; (B) = Based on data from smaller controlled trials; (C) = Based on expert opinion, open-label data, or usualcare experience; (D) = No acute efficacy 1 2 Some dosage guidelines are based on usual care experience and may differ from manufacturer’s package data. Tier 1 = Generic; Tier 2 = Preferred Brand; Tier 3 = Non-Preferred Brand. Cost is based on 30-day actual cost (not copay), and on generic, when available: $=$1 – 25; $$=$26 – 75; $$$=$76 – 150; $$$$= > $1500 3 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 13 MANAGEMENT OF BIPOL AR DISORDER TABLE 5. Medications used to treat bipolar disorder (continued)KUP1,2; LEC1,2; LEX; POST; STA1,2; STO1,2 Lithium Preparations Medication Class (common Use (strength of evidence1) brands) lithium carbonate (Eskalith, Eskalith CR, Lithobid) Mania, maintenance (A) Bipolar depression (B) Decreased efficacy in mixed episodes, rapid cycling, and comorbid substance abuse FDA-approved for treatment of acute mania and maintenance Dosage guidelines2 Initiate: at 300 mg twice daily; increase by ≤ 300 mg/day every 3 – 4 days Range: 600 – 1500 mg/day Acute Mania Target: Serum level 1 – 1.5 mEq/L Maintenance Target: 0.6 – 1.2 mEq/L Side effects and other comments Tier/ (see Table 6A on page 16 for 3 Cost monitoring guidelines) 1 •• Effective for reducing suicide riskCIP $ –$$ •• May be given once daily as tolerated; immediate release formulations generally given in doses divided 2–3 times/day •• Multiple drug interactions (e.g., NSAIDs, ACEIs, diuretics) •• Moderate weight gain. •• Common side effects include polydipsia, polyuria, acne, GI discomfort, hand tremor; most are serum-level related •• No significant sedation or stimulation lithium citrate aripiprazole (Abilify) 8 mEQ/5mL solution Mania, maintenance (A) Bipolar depression (C) FDA-approved (for acute treatment of manic and mixed episodes associated with bipolar 1 disorder) Atypical Antipsychotics MARCH 2016 Initiate: at 5 – 15 mg once daily Titrate: as tolerated to 30 mg/day, if clinically indicated Range: 15 – 30 mg/day asenapine Mania (A) Monotherapy — (Saphris) Bipolar depression, maintenance (B) Initiate: at 5 – 10 mg twice daily by mouth FDA-approved (for treatment of acute mania or mixed episodes associated with bipolar 1 disorder as monotherapy or in combination with lithium or valproate) Combination therapy — Initiate: at 5 mg twice daily lurasidone Mania, maintenance (C) (Latuda) Bipolar depression (B) Initiate: at 40 mg by mouth once daily (increase as clinically indicated) FDA-approved (for treatment of depressive episodes associated with bipolar 1 disorder as monotherapy or in combination with lithium or valproate) 1 $$$$ 3 $$$$ •• Common side effects include restlessness, stimulation, and nausea •• Minimal risk of extrapyramidal symptoms (EPS) other than akathisia •• Sublingual administration only; no eating or drinking for 10 minutes after placing under tongue •• Common side effects include headache, dizziness and oral hypoesthesia •• Minimal risk of EPS other than akathisia •• Minimal sedation and little to no weight gain Titrate: to 10 mg twice daily based on clinical response Range: 20 – 120 mg/day 3 $$$$ •• Medication must be taken with food (at least 350 calories) •• Common side effects include sedation, EPS, and nausea •• Little to no weight gain Strength of evidence key: (A) = Based on data from large controlled trials; (B) = Based on data from smaller controlled trials; (C) = Based on expert opinion, open-label data, or usualcare experience; (D) = No acute efficacy 1 Some dosage guidelines are based on usual care experience and may differ from manufacturer’s package data. 2 Tier 1 = Generic; Tier 2 = Preferred Brand; Tier 3 = Non-Preferred Brand. Cost is based on 30-day actual cost (not copay), and on generic, when available: $=$1–25; $$=$26–75; $$$=$76–150; $$$$= > $1500 3 4 Strength of evidence is based on use as an adjunct to lithium or divalproex. 14 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER TABLE 5. Medications used to treat bipolar disorder (continued)KUP1,2; LEC1,2; LEX; POST; STA1,2; STO1,2 Medication Class (common Use (strength of evidence1) brands) olanzapine (Zyprexa, Zydis) Mania, maintenance (A) Bipolar depression (B) 4 FDA-approved (for treating bipolar 1 Atypical Antipsychotics, continued disorder as follows): •• Acute mania or mixed episodes as monotherapy or in combination with lithium or valproate •• Maintenance treatment Dosage guidelines2 Initiate: at 10 mg at bedtime Titrate: by 5 mg increments at daily intervals Range: 5 – 20 mg at bedtime (may be split twice daily) olanzapine + fluoxetine (Symbyax) •• Bipolar depression in combination with fluoxetine quetiapine (Seroquel) Mania, bipolar depression, and maintenance (A) Initiate: at 50 – 100 mg at bedtime FDA-approved (for treating bipolar 1 Titrate: as clinically indicated disorder as follows): •• Acute mania or mixed episodes as monotherapy or in combination with lithium or valproate •• Maintenance treatment (in combination with lithium or valproate) •• Acute treatment of depressive episodes (bipolar I and II disorder) risperidone (Risperidal) Mania (A) Bipolar depression (C) Maintenance (B) FDA-approved (for treatment of acute mania or mixed episodes associated with bipolar 1 disorder as monotherapy or in combination with lithium or valproate) ziprasidone (Geodon) Mania (A) Bipolar depression (C) Maintenance (B)5 FDA-approved (for treatment of acute manic or mixed episodes associated with bipolar disorder with or without psychosis; for maintenance treatment of bipolar disorder in combination with lithium or valproate) Tier/ Cost 3 Side effects and other comments (see Table 6B on page 16 for monitoring guideines) 1 •• Significant sedation $ – $$ •• Severe weight gain •• Medium risk of extrapyramidal symptoms (EPS) •• Potential for dyslipidemia and hyperinsulinemia, case reports of diabetes risk •• IM formulation effective for acute agitation 1 $ – $$$ •• Significant sedation and moderate weight gain; dry mouth •• Lowest EPS risk of the atypical antipsychotics Range: 300 – 400 mg/day; up to 800 mg/day may be needed May be given once nightly as tolerated Range: 1 – 2 mg at bedtime Titrate: by 1 mg increments at daily intervals 1 $ •• Moderate sedation and weight gain; increases prolactin •• Minimal risk of EPS below 4 mg daily Range: 1 – 6 mg at bedtime; may be split to twice daily Initiate: at 40 mg twice daily with food Titrate: to 60 – 80 mg twice daily with food on day 2 Range: 40 – 80 mg twice daily with food 1 $$-$$$$ •• Poor absorption without food; for best results take once daily with evening meal (minimum 500 calories) •• Minimal sedation at lower doses; little to no weight gain •• Moderate risk of EPS •• Significant additional monitoring requirements (see Table 6B on page 16) IM formulation effective for acute agitation Strength of evidence key: (A) = Based on data from large controlled trials; (B) = Based on data from smaller controlled trials; (C) = Based on expert opinion, open-label data, or usualcare experience; (D) = No acute efficacy 2 Some dosage guidelines are based on usual care experience and may differ from manufacturer’s package data. In patients with repeated compliance issues, consider a long-acting injectable medication. 3 Tier 1 = Generic; Tier 2 = Preferred Brand; Tier 3 = Non-Preferred Brand. Cost is based on 30-day actual cost (not copay), and on generic, when available: $=$1 – 25; $$=$26 – 75; $$$=$76 – 150; $$$$= > $1500 4 Strength of evidence is based on use as an adjunct to lithium or divalproex. 5 Grade A evidence based on use in combination with fluoxetine 1 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 15 MANAGEMENT OF BIPOL AR DISORDER MARCH 2016 Monitoring Guidelines for Anticonvulsants and Lithium — Monitor (as clinically indicated) AND: KUP1,2; LEC1,2; LEX; POST; STA1,2; STO1,2 TABLE 6A. Anticonvulsants Test HLA-B*1502 genotype CBC w/differential carbamazepine screening prior to therapy1 FDA,CPIC every 2 – 4 wks X 2 mos, then every 3 – 6 mos Hepatic Function at baseline; then every 6 – 12 mos Renal Function divalproex lamotrigine oxcarbazapine screening prior to therapy1 FDA at baseline; then 1 – 2 wks after any dose change at baseline; then every 6 – 12 mos periodically at baseline at baseline at baseline and yearly at baseline; then yearly at baseline; every 6 mos Thyroid Function Pregnancy Test Lithium at baseline; then yearly at baseline Fasting Lipids Serum Sodium at baseline Serum Medication Level (Trough) 3 – 4 wks after any sustained dose adjustment at baseline; then periodically during first 3 mos of therapy Serum Ammonia 1 – 2 wks after any dose change 10 – 12 hrs after last dose, 4 – 5 days after initiation or dose change; then every 3 mos. when clinically indicated2 ECG at baseline and yearly Electrolytes at baseline Urinalysis at baseline TABLE 6B. Monitoring Guidelines for Atypical Antipsychotics — Monitor (as clinically indicated)3 AND:ADA, GOT Pregnancy Test at baseline, if indicated (see page 17) Fasting Lipids at baseline; at 12 weeks; then annually BMI initial measurement; then at 4, 8, and 12 weeks; then every visit HgA1c/fasting plasma glucose at baseline; at 12 weeks; then annually Blood Pressure at baseline; at 12 weeks; then annually Extrapyramidal symptoms (EPS) baseline, then at each visit 1 In patients of Asian descent, DO NOT USE if the HLA-B*1501 allele is present. 2 For unexplained lethargy, vomiting, or mental status changes 3 For ziprasidone (Geodon), also do baseline ECG if known heart disease, personal history of syncope, family history of early sudden death or congenital long QT syndrome. Also monitor ECGs as clinically indicated for symptoms of prologed QT interval (e.g., syncope). 16 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER TABLE 7. Medication considerations for SPECIAL CIRCUMSTANCES HEN1-4; KUP1,2; LEC1; LEX; MAR; STA2 Circumstance Medication Considerations Acute illness •• Lithium has been proven effective for reducing the risk of suicide in patients with acute illness.CIP •• Titrate medication dosage rapidly (except for lamotrigine — never rapidly titrate lamotrigine). •• Use respective adjunctive medications at beginning of treatment. •• Start co-therapy with two primary mood stabilizers from separate classes at beginning of treatment. Akathisia •• Consider a cautious antipsychotic dose reduction •• Use lorazepam 0.5 mg twice daily (B); titrate as needed to manage symptom severity. •• Use propranolol 10 mg twice daily (C); gradually increase to 20 mg three times daily. Avoid in patients with asthma; watch for bradycardia and hypotension. •• Use benztropine 1 mg twice daily (C); increase to 2 mg twice daily as needed and tolerated. Anxiety, agitation, and/ or insomnia •• Augment with a sedating atypical antipsychotic medication (see page 13), adjunctive sleeping pill, or sedative (benzodiazepine such as clonazepam, lorazepam, alprazolam) 0.5 – 6 mg, in divided doses (A). Bipolar II disorder •• The hypomanic state of bipolar type II is often experienced as a functional and non-pathologic state. Aggressive treatment of this state may lead to patient non-compliance. The consequences of not treating hypomania are unknown. Elderly patient •• Consider half doses of medication. Older patients are more susceptible to lithium toxicity and suffer more side effects from medication. •• Suppression of manic symptoms, anxiety, or agitation with sedatives is a short-term solution. Avoid or use cautiously in patients with a history of substance abuse. •• Due to the possibility of lower manic conversion rates, antidepressant use may be less risky with this population compared to the bipolar type I population. However, antidepressants should be avoided in patients who are rapid cycling. •• Monitor for increased suicide risk, more accidents, and self-neglect. •• Atypical antipsychotic medications may increase the risk of death in patients with dementia. Female of child-bearing years •• Use anticonvulsant mood stabilizers with caution — many are generally regarded as teratogens. •• For patients that plan to become pregnant, consider lamotrigine as first-line therapy (C). •• Failing lamotrigine, consider quetiapine or risperidone as second-line therapies (C). Lurasidone may also be considered as secondline therapy. •• For treatment refractory patients, lithium is considered a reasonable option. While it is generally considered teratogenic (increased risk for cardiac defects), the absolute risk is low. •• Evaluate sexual activity, menstrual status, and birth control use at every visit for child-bearing age females on divalproex sodium, lithium, or carbamazepine. Insomnia •• May be chronic in patients with bipolar disorder. Lack of adequate sleep may be both a sign of and a precipitant to relapse. •• Use adjunct sleeping medications. Benzodiazepine and related sedatives are helpful as sleep aids as well as for treatment (with mood stabilizer) of residual agitation and anxiety, though habit-forming sedatives should be avoided in patients with history of substance abuse. •• Educate patient on proper sleep hygiene: No evening caffeine or tobacco; no daytime napping; avoid reading and TV in bed; go to bed when sleepy; get out of bed if unable to fall asleep in less than 30 minutes. Pregnancy Risk of relapse is high for those who discontinue mood stabilizers; near-term pregnant women are vulnerable to relapse.YON For patients with bipolar depression: •• Consider lamotrigine as first line therapy (C). •• Consider quetiapine as second-line therapy (C). Lurasidone may also be considered as second-line therapy. •• Treatment refractory patients are often treated with fluoxetine plus olanzapine, lamotrigine plus lithium, or electroconvulsive therapy (ECT). For patients with manic, hypomanic or mixed episodes: •• First-generation antipsychotics (e.g. haloperidol) are the preferred first-line therapy (B). •• Consider risperidone, quetiapine, or olanzapine (in that order) as second-line therapy (C). •• Treatment-refractory patients are often treated with lithium, electroconvulsive therapy (ECT), or lithium plus an antipsychotic. ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 17 MANAGEMENT OF BIPOL AR DISORDER TABLE 7. Medication MARCH 2016 considerations for SPECIAL CIRCUMSTANCES (continued) HEN1-4; KUP1,2; LEC1; LEX; MAR; STA2 Circumstance Medication Considerations Rapid cycling (four or more mood cycles per year) For patients with bipolar depression: •• Quetiapine is the preferred first-line therapy (C). •• Consider lamotrigine, lithium, and fluoxetine plus olanzapine second-line agents, in order of preference (C). •• Failing the above, treatment refractory patients should be referred to a psychiatrist and potentially considered for electroconvulsive therapy (ECT), rather than additional pharmacotherapy trials (C). For patients with manic, hypomanic or mixed episodes: •• Consider risperidone, aripiprazole, or olanzapine monotherapy as first-line therapy (B). •• Second-line agents include lithium, valproate, quetiapine, haloperidol or carbamazepine, in order of preference (C). •• Failing the above, treatment refractory patients should be considered for combination therapy with either lithium or valproate and a first-line atypical antipsychotic. Alternately, in cases of severe mania, consider combination therapy a first-line option (C). •• For severe mania unresponsive to a single trial of combination pharmacotherapy, consider addition medication trials over electroconvulsive therapy (ECT). However, for severe mania unresponsive to 4 – 6 trials of combination pharmacotherapy, consider referral to a psychiatrist for electroconvulsive therapy (ECT) rather than additional pharmacotherapy trials (C). For all patients: •• Optimize thyroid function. •• Augment with psychotherapy. Side effects intolerable prior to efficacy •• Consider lower dose. •• Change medications. •• Treat with low dose of two primary mood stabilizers. Switch to opposite pole or mixed symptoms •• Add mood stabilizer with efficacy for appropriate pole. •• If depressed, raise lithium level to more than 0.8 mEq/L, add lamotrigine, quetiapine, OR add an antidepressant. Avoid TCAs, venlafaxine, and duloxetine. •• If manic or mixed, discontinue antidepressant (if that caused switch) or add a primary mood stabilizer for mania/ mixed mania. •• Patients who have a history of manic conversion on antidepressants are at high risk of future conversion with antidepressants. Substance use disorder •• Avoid lithium as a primary mood stabilizer in these patients. •• Give appropriate referral and treatment for substance use issues. •• Use habit-forming sedatives with caution Thyroid dysfunction •• Thyroid supplements may be necessary for some patients on lithium, since lithium carbonate can interfere with thyroid functioning. Consider treating subclinical hypothyroidism in patients who have resistant depression or rapid cycling. Weight gain >5% of initial weight or weight gain prevention •• Modify treatment plan to include exercise and calorie restriction. •• Follow weight, serum lipids, and fasting glucose. •• Consider medication change — atypical antipsychotics may be associated with more weight gain than other mood stabilizing agents. •• Consider adjunctive use of metformin (B) or topiramate (B). Three small controlled studies showed diminished or reversed weight gain with metformin in patients who were taking atypical antipsychotics. One large trial showed an average three-year weight loss of 2.5% with metformin therapy, which was maintained over a 10-year observation period. A meta-analysis of six trials showed an average 6-month weight loss of 6.5% with topiramate therapy. Worsening mania •• Assess medication adherence. •• Raise dose of existing mood-stabilizing medications AND/OR add second mood stabilizer for mania. •• Discontinue antidepressant if it is considered a precipitant. Strength of evidence key: (A) = Based on data from large controlled trials; (B) = Based on data from smaller controlled trials; (C) = Based on expert opinion, open-label data, or usual-care experience; (D) = No acute efficacy 18 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER Psychosocial therapy Patients with bipolar disorder suffer a variety of psychosocial consequences — stigmatization; interpersonal issues in marriage, family, childbearing, and parenting; academic, occupational, legal, and social problems — related to acute episodes (typically resulting from reckless and/or inappropriate behaviors or being withdrawn or violent). The resultant stress of past episodes often sets these patients up for ongoing vulnerability to future episodes. In addition, patients struggle to adhere to a long-term pharmacological treatment regimen with frequently unpleasant side effects. As a result, recent research-based clinical guidelines recommend that psychosocial therapy be an essential part of a bipolar disorder treatment plan, especially for maintenance treatment to: APA3, CAN, VA ADJUNCTIVE PSYCHOSOCIAL THERAPY GOALS APA3,CAN,MIK Help patients better: • Understand and accept the nature of their chronic illness and treatments • Adhere to medication regimens • Recognize early warning signs of and stressors that trigger relapse • Regulate their emotions and improve functioning • Communicate and solve problems within family relationships • Reduce stress • Increase patient functioning between episodes • Decrease likelihood and severity of future episodes • Regulate sleep/wake cycles and other Treatment strategies vary in terms of format (individual, group, or family unit), duration of treatment, patient cohort (in remission, recovering from an acute episode, or both). As part of a treatment plan, therefore, psychosocial treatment strategies should be individualized over time for each patient in terms of form, intensity, and focus.APA3 Help family members/caregivers: Evidence-based adjunctive psychosocial treatments for bipolar disorder include: daily routines • Avoid substance misuse • Increase illness management and their own self-care skills • Decrease their own depressive symptoms • Decrease their health-risk behavior • Individual cognitive-behavioral therapy (CBT) — Likely the most extensively researched modality as adjunctive therapy, CBT research reflects varying protocols and outcomes in comparison to other psychosocial treatments.MIK CBT is recommended for those in remission from acute mania who have experienced fewer than 12 previous acute episodes. With this treatment approach, patients learn about their symptoms, course of illness, and treatments as well as techniques for cognitive restructuring and problem-solving strategies for adapting activity levels to mood, detecting early signs of relapse, and implementing prevention strategies. Providers may want to consider booster sessions after 18 months to maintain treatment benefits.VA • Individual and/or group psychoeducation — This treatment approach focuses on helping patients become active partners in their treatment by learning: –– The nature and course of the illness –– Benefits/risks of treatment options –– How to recognize early signs and stressors that may signal relapse –– How sleep regulation and substance misuse impact likelihood of relapse Psychoeducation can involve the patient’s family members/caregivers if the patient agrees and providers should consider structured group psychoeducation, which has been validated in two randomized trials as effective for reducing the duration of patients’ manic episodes, lowering mania scores, and significantly improving patients’ social functioning and quality of life.MIK In addition, brief group psychoeducation has been found to be as effective as longer-term individual CBT at a significantly reduced cost (an 85% savings).PAR • Interpersonal and Social Rhythm Therapy (IPSRT) — This treatment approach addresses resolving patient-specific problems and focuses on stabilizing sleep/wake rhythms as well as patterns of social routines and stimulation. IPSRT uses a selfreport tool, the Social Rhythm Metric, to track routines and mood. Designed for use with patients in remission, the treatment homes in on individualized problem resolutions and strategies for preventing problem recurrence. Some research indicates that IPSRT may be associated with longer time between episodes, better occupational functioning for those undergoing acute treatment, and even improved depression scores when used as monotherapy for those with bipolar II disorder.MIK ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 19 MANAGEMENT OF BIPOL AR DISORDER THE ROLE OF FUNCTIONAL REMEDIATION Those with bipolar disorder struggle with both social and occupational functioning — challenges that represent both clinical concerns as well as social and economic burdens. Functional remediation programs address struggles patients face with attention, memory, and executive functioning in their daily routines. Elements of IPSRT (see page 19) also focus on functional remediation by addressing stabilization of daily routines and sleep/wake cycles. Adjunctive psychosocial interventions focused on functional remediation have been associated with significant improvements in occupational and interpersonal functioning among patients with both bipolar I and II disorder. In a 2-year study of patients with bipolar I disorder, IPSRT combined with medical management rapidly improved occupational functioning as compared to other psychosocial approaches (especially among women), and these gains were maintained for two years following the study. FRA A multicenter, randomized controlled trial of 239 euthymic patients with bipolar disorder compared functional remediation with psychoeducation and treatment as usual over 21 weeks. Results indicated significant improvements in both occupational and interpersonal functioning.TOR MARCH 2016 • Family Focused Therapy (FFT) — Targeting couples and families of patients stabilizing from acute episodes, this treatment approach includes both the patient and the family members and offers an initial assessment followed by education about: –– The illness, medication adherence, early warning signs of relapse, and relapse prevention strategies –– Communication and problem-solving skills to improve family relationships While patients whose families experience more conflict and intensity of relationships may benefit the most, research indicates that overall, patients involved in FFT as an adjunct to pharmacotherapy may experience a 35 – 40% reduction in recurrence rates over 2 years as compared to those undergoing brief psychoeducation and pharmacotherapy.MIK In addition, FFT can help caregivers increase illness management skills as well as their own self-care, which is associated with decreased depressive symptoms and health-risk behavior among caregivers as well as decreased depressive symptoms in patients.CAN Electroconvulsive therapy (ECT) With ECT, patients undergo a generalized cerebral seizure via administration of low-level electrical current to the scalp while under general anesthesia and muscle relaxation. Treatment usually requires 6 – 12 sessions over a 2- to 4-week period. Although considered a standard treatment for unipolar depression, ECT has also been proven effective for acute mania, bipolar depression, mixed affective states, and especially for treatment-resistant bipolar disorder.LOO Other typical indications for the use of ECT include multiple treatment failures, pregnancy, prior positive ECT response, and patient preference. Studies also indicate that ECT may be effective as a first-line treatment to achieve rapid clinical response in urgent cases where patients present with severe suicidal ideation and behaviors, severe psychosis, malignant catatonia, or with dangerous, depression-related refusal of fluid and food. APA4, HUS, KEL1, KEL2 There are no absolute medical contraindications for using ECT; however, relative risk may differ depending on a patient’s clinical situation.APA4 Because of potential side effects, such as confusion and short-term memory loss (as well as side effects associated with anesthesia), ECT has typically been considered with treatmentresistant bipolar disorder patients. However, recent research indicates that these patients do not generally suffer adverse neurocognitive consequences and in fact, ECT may also be associated with a favorable long-term influence on some cognitive functions.KES, VER, BOD Care management With routine phone or clinic contact, care managers can educate patients regarding their care, set expectations, assist with social emergencies, and direct patients to return to the clinic sooner rather than later. Care managers offer both knowledge and a supportive relationship to patients — both of which are necessary for success. Patients who receive this type of care for depression have much better results than those who don’t. Working inside and outside the clinic, a care manager can assist with the following: • Treatment adherence (medications and/or psychotherapy) • Patient education, self-management, and reinforcement of ongoing physician, patient, and family contact • Communication and coordination between mental health and primary care • Support with requests for consultation • Improving timely contact with patients and monitoring their response 20 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER FOLLOW UP AND MAINTENANCE Since bipolar disorder is a chronic and reoccurring illness, it usually requires regular follow-up, lifetime maintenance pharmacotherapy, and ongoing, objective outcomes assessment. Sustained remission lowers relapse risk. Follow-up schedule Multimodal treatment of this complex disorder demands regular, lifelong follow-up. Objectives of follow-up include: • Adjusting medications and addressing side effects • Monitoring lab values (e.g., lithium serum levels) as indicated • Managing comorbidities • Continuing/coordinating therapy and education for patients and families • Measuring outcomes See below for a recommended follow-up schedule: TABLE 8. Recommended follow-up schedule When Why 1 to 2 weeks after diagnosis and initial medication therapy •• Assess initial response to treatment, assess outcome. Every 4 weeks after diagnosis and initial medication therapy until patient is much improved (CGI global improvement score 1 – 2). •• Achieve target doses. •• Assess functional outcome (see page 18). •• Monitor side effects and adherence. •• Assess educational needs. •• Assess therapeutic alliance (see sidebar). THERAPEUTIC ALLIANCE Clinicians should assess therapeutic alliance on a routine basis. Therapeutic alliance refers to how well the patient and clinician are working together to manage the patient’s illness. The patient’s perception of this relationships is related to compliance and outcome. •• Assess for substance abuse (see page 8). Even limited alcohol use can destabilize the course of bipolar disorder.GOLD At least every 6 months •• Monitor symptoms, lab values, and functional outcomes. PRN •• Respond to worsening of symptoms or side effects, reinforce compliance. STICK WITH WHAT WORKS Remission and maintenance Bipolar disorder is a recurrent illness. The goal of treatment is full, continuous remission of symptoms. Nearly 3 in 4 patients will relapse within 5 years, and many patients who do not have formal relapse will still exhibit significant residual symptoms. More than 90% of patients who experience one manic episode requiring hospitalization will have a second episode. Patients hospitalized for mania are more likely to have a mania relapse than a depressive relapse. Even with lifetime maintenance therapy, patients may experience only partial remission of symptoms.TOH Due to the recurrent nature of bipolar disorder—and high probability of relapse— lifetime maintenance regimens of medication are recommended following the successful treatment of an acute episode. Although few studies involving patients with bipolar II disorder have been conducted, consideration of maintenance treatment for this form of the illness is also strongly warranted. One long-term follow-up study showed that patients with bipolar II disorder have chronic depressive symptoms more than half of the time.JUD1, JUD2 Whatever medication or medication regimens achieved remission of an acute episode should be continued without reduction of dosage as tolerated. The medications with the best empirical evidence (see medication details on pages 13 – 16) to support their use in maintenance treatment include the following:KUP1,2; LEC1,2; LEX; POS; STA1,2; STO1,2 • Lithium, valproate, olanzapine, and aripiprazole (better at preventing manic relapse) • Quetiapine when used in combination with lithium and valproate • Ziprasidone when used in combination with fluoxetine • Lamotrigine (better at preventing depressive relapse) ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 21 MANAGEMENT OF BIPOL AR DISORDER MARCH 2016 BE CONSISTENT Outcomes assessment tools Measure treatment outcomes in a consistent, comprehensive, and efficient way, using the tools described on these two pages. Traditionally, symptomatic outcome measures — such as the Young Mania Rating Scale or the Hamilton Depression Rating Scale — have been used in bipolar disorder. These measures focus specifically on the core disease symptoms and are useful in research. However, bipolar disorder is a highly comorbid condition; over half of patients also suffer anxiety disorder and substance abuse disorders throughout their lifetime. Medication side effects can also add a significant burden. For these and other reasons, basic symptom measures do not adequately track these issues and often miss significant functional impairment important to both patients and clinicians. To address shortcomings in traditional outcomes measurement, this CPM recommends two essential types of clinical measures: • The clinician-rated Clinical Global Impressions (CGI) Scale for treatment responseGUY • The patient-rated Intermountain Disability Scale for functional response In addition to these clinical measures, having selected patients use a daily mood chart (see page 23) to track function impairment is also useful. ASSESS SEVERITY ROUTINELY Rate and record the severity score at the initial visit and at all subsequent visits. The Clinical Global Impressions (CGI) ScaleGUY Requiring only 5 minutes or less to complete, the Clinical Global Impressions (CGI) Scale is a simple, valid measure of treatment response. In its simplest form, the clinician rates a patient’s severity of illness and response to treatment. This scale tracks well with symptom scales, and clinicians often closely agree with each other when scoring the same patient. To use the CGI Scale, rate the severity of illness at the initial visit and all subsequent visits. Based on your experience with this disorder, use the 1 – 7 scale below. Severely ill patients routinely suffer comorbid illness; incorporate this factor into the rating. Severity scale 1 – 7: 1 2 3 normal, not ill borderline ill mildly ill 4 5 moderately markedly ill ill 6 7 severely ill extremely ill The Intermountain Disability Scale Intermountain’s functional disability rating scale (on the next page) can be downloaded at: https://intermountainhealthcare.org/ext/Dcmnt?ncid=526842760 Instruct the patient to rate their level of disability by asking, “In the past 2 weeks, how much have your mental health symptoms interfered in the following areas of life?” Patients should rate each of the three domains (family life and home responsibilities, work or school, and social or leisure activities), providing a total functional disability score from 0 – 30. 22 ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER Intermountain Disability Scale Access the Intermountain Disability Scale at: https://intermountainhealthcare.org/ ext/Dcmnt?ncid=526842760 Daily mood charting RATE IMPAIRMENT DAILY Daily mood charting provides a way for patients to rate impairment caused by depressive or manic systems in relation to daily medications, interpersonal stress, sleep, and other variables. Use of a mood chart is widely recommended for patients with rapid cycling, particularly those who have mood cycling within a single month. Recording a mood along with any medications taken, medication changes, or other events can provide evidence for which interventions are helpful or destabilizing. Instruct the patient to use this chart every day to rate impairment caused by symptoms, medications, stress, sleep, and other variables. Daily Mood Tracking Chart Directions: At the end of each day, use this calendar to record your medications, overall mood, hours of sleep, and other symptoms and/or life events. This will help you and your healthcare provider monitor and improve your treatment. Month: Patient name: Year: DATES 1. CHART YOUR MEDS (record number of pills each day) Name of medication Pill strength 1 2. CHART YOUR MOOD ( your mood each day and how it Mania has affected your ability to function at work, home, or school) Depression 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 # pills/day 4 Severe: Completely unable to function or hospitalized 3 Moderate to High: Great difficulty functioning 2 Moderate: Some difficulty functioning 1 Mild: Usual routine not affected much; may be more active than usual 0 Stable mood: no mania or depression 1 Mild: Usual routine not affected much; depressed mood 2 Moderate: Some difficulty functioning 3 Moderate to high: Great difficulty functioning 4 Severe: Completely unable to function or hospitalized 3. RECORD OTHER HABITS AND EVENTS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Access this mood tracking chart under the “bipolar disorder” topic at: intermountainphysician.org/ clinicalprograms # hours slept last night Used alcohol or drugs ( if yes – or enter number of drinks) Other symptoms or life events ( if yes; date and describe on back) Example symptoms: pain, taking risks, feeling paranoid or irritable Example life events: argument, promotion, family conflict © 2008–2015 Intermountain Healthcare. All rights reserved. Patient and Provider Publications MH200 -12/15 *50179* Trc 50179 ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 23 MANAGEMENT OF BIPOL AR DISORDER TOOLS USED FOR SCREENING AND DIAGNOSIS Although there is disagreement within the specialty of child psychiatry regarding bipolar diagnoses, there are reasonable guidelines and tools for diagnosing childhood and adolescent bipolar disorder. However, it is critical that the care provider use the symptom expression information at right and not rely solely on screening instruments. Validated tools include: • The MDQ-A (Mood Disorder Questionnaire-Adolescent). This screening instrument has been validated in adolescents, with the parent report version having the greatest sensitivity and specificity.WAG • The Young Mania Rating Scale. This scale was developed to rate acute mania severity but also functions as a screening instrument when rated by a parent. The P-YMRS is the parent-rated version of this scale.GRA • FIND guidelines. Childhood bipolar disorder may present with symptoms that are frequent, brief, and intense with outbursts and behavioral dysregulation fundamentally different from the adult presentation of the illness. The FIND guidelines below include duration and intensity criteria, and are recommended by many researchers to ascertain the presence or absence of manic symptoms.KOW F I N D GUIDELINES FOR MARCH 2016 BIPOLAR DISORDER IN CHILDREN AND ADOLESCENTS Many emotional and behavioral illnesses of childhood have symptoms that converge and confuse the identification and appropriate treatment of bipolar disorder in children and adolescents. Presentation of symptoms often differs from that in adults, and children tend to have higher rates of chronicity, mixed states, and rapid cycling. A reliable diagnosis of bipolar disorder in the pediatric population depends on symptoms: • Occurring in concert rather than sequentially • Being considered in the context of age and comorbidity The diagnosis of cyclothymic disorder in children and adolescents is one year of both hypomanic and depressive episodes without ever meeting criteria for mania, depression, or hypomania, while the requirement for adults is 2 years. Symptom expression Symptom expression of bipolar disorder in children and adolescents differs from that of adults and is influenced by developmental changes, temperament, and reaction to environmental stress. Distinct periods of depression and mania are less likely in younger populations, and these patients may present with chronic symptoms of irritability, along with difficulties regulating moods, emotions, and behavior. Younger children may also have periods of agitation, irritability, and oppositionality as generic symptoms of any severe mental illness. Mania in adolescents presents many diagnostic challenges based on historical reporting. Both adolescents and their parents may either minimize symptoms of mania (to downplay the seriousness of the situation) or exaggerate these symptoms (hoping that a bipolar disorder diagnosis will explain the difficulties the patient is experiencing). Symptoms that typically present include: PEDIATRIC PATIENTSKOW • Grandiosity: Determine the child’s ability to distinguish between pretending and These guidelines can help clinicians ascertain the presence or absence of manic symptoms: • Euphoria/Irritability: Review these moods in the context of special events, the F I N D 24 Frequency. Symptoms occur most days of the week. Intensity. Symptoms are severe enough to cause extreme disturbance in 1 domain or moderate disturbance in 2 or more domains (school, home, friends, etc.) Number. Symptoms occur 3 or 4 times per day. Duration. Symptoms occur 4 or more hours a day total (not necessarily contiguous hours) reality to establish if grandiose symptoms are due to bipolar disorder. behavior of other children, and exposure to steroids or substance abuse. Irritability that results in major “meltdowns” lasting hours for trivial reasons should be separated from less severe irritable moods. • Decreased need for sleep: A child with bipolar disorder may need 2 hours less sleep per night (adjusted for age without daytime fatigue). Children with limited sleep due to mania are often active during the night whereas depressed children may lie in bed and brood. • Pressured speech: Speech is louder, faster, and more difficult to interrupt than a child with ADHD who talks a lot. • Mood lability: For adolescents, mood lability may be the way mania presents. In fact, it is not unusual for patients to experience mixed manic and depressive features of a mood disorder, a more common symptom picture than the persistent euphoria found in adults. ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER • Racing thoughts: These thoughts should be severe enough to interfere with daily activities. Parents can help distinguish what behaviors are different than baseline. • Distractibility: Compare distractibility to baseline symptoms when mood is euthymic. Symptoms in children with comorbid ADHD should have distractibility worse than baseline distractibility. • Increase in goal-directed activity/agitation: Mania may be associated with periods of copious drawing, writing, or play activities. This should be above and beyond normal and associated with other diagnostic symptoms. • Excessive Involvement in Pleasurable or Risky Activities: Hypersexual behaviors may be present in children with or without a history of childhood abuse. This behavior may be exhibited in an anxious and compulsive manner. Hypersexuality in children due to mania can appear as erotic and pleasure-seeking behaviors that might be appropriate between consenting adults in private but grossly inappropriate in a child. Sexual and/or seductive advances towards a parent would not be unusual. • Psychosis: It is important to differentiate hallucinations or delusions from common childhood perceptual disturbances such as hearing one’s name called or other distortions when falling asleep. Symptoms of psychosis frequently occur in adolescents experience bipolar disorder. Differential diagnosis and comorbidity One of the biggest challenges is differentiating children and adolescents with mania from those with attention deficit hyperactivity disorder (ADHD). These patients should also be screened for other problems such as learning problems, substance use, and conduct disorders — and those problems should be treated concurrently. There are high rates of comorbid disruptive, impulse-control, and conduct disorders that accompany the bipolar diagnosis. Additionally, in disruptive mood dysregulation disorder (a depressive disorder), children present with irritability as the chief complaint. Temper outbursts occur on average more than 3 times per week, but the moods in between the outbursts are “persistently irritable” unlike with bipolar disorder where there is often some cycling nature. Treatment guidelinesKOW Treatment of bipolar disorder in young patients generally reflects that of adult patients — and should include patient/family education, psychotherapy, and pharmacotherapy. Young patients experiencing bipolar symptoms can benefit from psychosocial interventions (see pages 19 – 20). In addition, patients may require specialized educational programming, day treatment, and vocational training. THE IMPORTANCE OF REFERRAL Bipolar disorder is relatively rare in children and complicated to diagnose. In terms of mania, “Bipolar ‘mood episodes’ include unusual mood changes along with unusual sleep habits, activity levels, thoughts, or behavior. In a child, these mood and activity changes must be very different from their usual behavior and from the behavior of other children.”NIH Highly irritable children are more likely to have ADHD or an anxiety or depressive disorder. Red flag symptoms for diagnosing mania in this patient population include:SHA • Rage outbursts or verbal or physical aggression — The patient may be easily frustrated or provoked. • Episodes of requiring little sleep — The patient gets less sleep frequently without suffering any loss of energy. • Spontaneous mood shifts — The patient may be giddy, then depressed, then angry without any apparent trigger for the mood shifts. • Grandiosity – The patient may exhibit a grossly inflated belief in himself beyond typical boastfulness. • Agitation or mania when taking an antidepressant — The patient may have had symptoms of being unusually edgy, happy when taking an antidepressant. Given the uncertainty and potential complications in diagnosing and treating bipolar disorder in this population, consultation with or referral to a child mental health specialist is recommended before initiating treatment. The literature on the use of ECT (see page 20) in pediatric bipolar patients is extremely limited, and the treatment should only be considered for adolescent patients suffering from bipolar I disorder with severe symptoms of mania or depression that are unresponsive to multiple medication therapies. ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 25 MANAGEMENT OF BIPOL AR DISORDER MARCH 2016 FDA-APPROVED MEDICATIONS Medications The following medications are approved for treating bipolar disorder in children and adolescents as indicated: The choice of the medications used to treat pediatric bipolar disorder should be based on evidence of efficacy, the phase of illness (manic versus depressive symptoms), the drug’s side-effect profile, the patient’s history of medication response, and patient and family preferences. • lithium carbonate (Eskalith, Eskalith CR, Lithobid) — Approved for ages >12 years as monotherapy for acute mania and maintenance • aripiprazole (Abilify) — Approved for ages >10 years (as monotherapy or in combination with lithium or valproate (or divalproex) for acute mania • asenipine (Saphris) — Approved for ages >10 years as monotherapy for acute mania/ mixed episodes • olanzapine (Zyprexa, Zydis) — Approved for ages >13 years as monotherapy for acute mania/mixed mania and maintenance • olanzapine (Zyprexa, Zydis) in combination with fluoxetine (Prozac) — Approved for ages 10–17 for treatment of bipolar depression • quetiapine (Seroquel) — Approved for ages >10 years as adjunct and monotherapy for acute mania • risperidone (Risperidol) — approved for ages >10 years (as monotherapy for acute mania/mixed episodes Prescribing guidelines emphasis a stepwise nature of medication management as well as rationale for combining medications. At each step in pharmacotherapy, the physician is balancing the benefits and risks of either staying with a current regimen (if the patient appears to be stable or improving) or changing medications or doses to optimize treatment. This process should be very patient-specific, with the following key issues guiding decision making at each step:SHAI • Making only one medication change at a time • Addressing the most problematic symptom or cluster of symptoms first • Reducing the number of medications that will eventually be needed • Making management of adverse effects a priority when warranted • Targeting symptoms that appear to trigger other symptoms • Preferring medications that work quickly Both the range of symptoms present with bipolar disorder and the symptoms that occur as a result of comorbidities often make medication management particularly challenging for children and adolescents. Combining medications is often appropriate when:SHAI • Using an augmentation agent to address only partial response when symptoms either improve but not to a degree that lessens significant distress or when symptoms fail to improve at all • Targeting a specific symptom that causes significant distress such as insomnia • Cross-tapering medication that is not working as expected with another medication • Treating symptoms of comorbid disorders such as those with ADHD or anxiety disorder CARE MANAGEMENT The follow-up and maintenance care of children and adolescents as well as outcomes assessment tools used follow the same processes as detailed for adults on pages xx through xx. Note that, for a younger child, a parent or other caregiver would be completing the forms. 26 Use the dosage guidelines in the medication table (page 27) for treating children and adolescents. For each medication, refer to the adult medication tables on pages 13 through 15 for tier/cost and side effect information that pertain to all populations. Dosages must be modified for age, and response to treatment must be carefully monitored. Side effects — particularly weight gain — may be exaggerated in children, and children are more prone to medication toxicity. Maintenance and medication monitoring Patients are likely to require maintenance therapy to prevent symptom relapse with a recommended trial of 12 to 24 months after an acute manic episode. Decisions to continue treatment must be weighed along with risks of medication side effects. Recommended medication monitoring for children and adolescents is the same as for adults (see Tables 6A and 6B on page 16). ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER TABLE 9. Medications for treating children and adolescentsELB, LEC2, LEX, STA1, STA2 Strength of Evidence1 Dosage guidelines2 /Notes (see pages 13 – 16 for specific medication side effects and monitoring guidelines) divalproex sodium (Depakote, Depakote ER) Not FDA approved for this population Mania, bipolar depression, and maintenance (C) Children: •• Initiate at 125 mg 2 – 3 times daily •• Increase gradually until side effects limit dose or therapeutic plasma levels are reached •• Range: 1000 – 1250 mg/day lithium carbonate (Eskalith, Eskalith CR, Lithobid) Mania, bipolar depression (C) maintenance (B) Ages 6 – 12 years: •• Initiate at 15 mg/kg/day in 3 – 4 divided doses •• Adjust dose weekly based on serum concentrations •• Range: 15 – 60 mg/kg/day (do not exceed adult dosage) aripiprazole (Abilify) Mania, maintenance (B), bipolar depression (C) Ages ≥ 10 years: •• Initiate at 2 mg once daily x 2 days •• Increase to 5 mg PO once daily x 2 days, then may increase in 5 mg increments •• Range: 10 – 30 mg/day asenapine Mania, maintenance (B), bipolar depression (C) Ages ≥ 10 years (Note: Sublingual administration only; no eating/drinking for 10 minutes after placing under tongue): •• Initiate at 2.5 mg twice daily •• Increase to 5 mg twice daily after 3 days, then to 10 mg twice daily in another 3 days based on tolerability olanzapine3 (Zyprexa, Zydis) Mania, maintenance (B) bipolar depression (B)4 Ages 6 – 12 years: •• Initiate at 2.5 mg at bedtime •• Increase in 2.5 – 5 mg increments •• Range: 10 – 20 mg/day Ages ≥ 12 years: •• Initiate at 2.5 – 5 mg at bedtime Increase in 2.5 – 5 mg increments weekly •• Range: 10 – 20 mg/day combined with Bipolar depression: ages 10 – 17 (C), ages 6 – 10 (D) Ages 6 – 10 years: •• Initiate at 5 mg •• Increase as clinically indicated Ages 10 – 17 years: •• Initiate at 10 mg •• Increase as clinically indicated quetiapine (Seroquel) Mania, maintenance (B) bipolar depression (C) Ages ≥ 10 years (Note: May be given once nightly if tolerated): •• Initiate at 25 mg twice daily •• Increase to 50 mg twice daily on day 2, then 100 mg twice daily on day 3, 150 mg twice daily on day 4, and 200 mg twice daily on day 5. •• Range: 400 – 600 mg/day in divided doses risperidone (Risperidal) Mania, maintenance (B) bipolar depression (C) Ages ≥ 10 years: •• Initiate at 0.5 mg at bedtime •• Titrate by 0.5 – 1 mg increments at daily intervals, as tolerated •• Range: 0.5 – 2.5 mg at bedtime (may be split twice daily) ziprasidone (Geodon) Not FDAapproved for this population5 Mania (B) bipolar depression, maintenance (C) Ages ≥ 10 years: •• Initiate at 20 mg once daily with food •• Titrate as tolerated •• Range: 60 – 80 mg/day divided twice daily (weight ≤ 45 kg) or 120 – 160 mg/day divided twice daily (weight > 45 kg) Metallic salt, antimanic Anticonvulsants Class Medication (common brands) Atypical Antipsychotics (Saphris) fluoxetine (Prozac, Symbyax) Adolescents: •• Initiate at 250 mg 2 – 3 times daily •• Increase gradually until side effects limit dose or therapeutic plasma levels are reached •• Range: 1000 – 2500 mg/day •• Target: Serum level 50 – 125 mcg/mL (mid to upper range generally required) Ages ≥ 12 years: •• Initiate at 300 mg twice daily •• Increase by ≤ 300 mg per day every 3 – 4 days •• Range: 600 – 1800 mg/day •• Target: Serum level 0.8 – 1.2 mEq/L Strength of evidence key: (A) = Based on data from large controlled trials; (B) = Based on data from smaller controlled trials; (C) = Based on expert opinion, open-label data, or usual-care experience; (D) = No acute efficacy. NOTE: See FDA-approved medication information for this population in the sidebar on page 26. 1 Some dosage guidelines are based on usual care experience and may differ from manufacturer’s package data. 2 Zyprexa is ONLY FDA-approved for treatment of acute bipolar depression for ages 10 – 17 in combination with fluoxetine and for treatment of acute manic or mixed episodes for ages 13 – 17. 3 4 Strength of evidence is based on use as an adjunct to lithium or divalproex. 5 While an FDA advisory panel has advised that ziprasidone is effective in patients 10 – 17 years of age for the treatment of mixed and manic episodes of bipolar disorder, they were unable to conclude that it was safe due to the large number of subjects lost to follow-up and ambiguity within QTc prolongation data ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 27 MANAGEMENT OF BIPOL AR DISORDER USING TEACH-BACK STRATEGIES What is Teach-back? — Teach-back is a MARCH 2016 PATIENT/FAMILY EDUCATION Patient and family education can lead to better compliance and treatment outcomes. Review the available patient education materials (see page 29) and resources for using teach-back strategies (see the information at left and the Teach-back Flashcard). way to confirm that patients understand what we tell them using open-ended questions that invite the patient and family to “teach-back” the information to us. It’s not a test of the patient’s knowledge — it’s a test of how well we explained something. In addition to basic information about the symptoms, neurobiologic basis, and treatment of the disease, patient education should include the following topics: Why is it important? — Not • Warning symptoms and prodromal symptoms. Symptoms may arise weeks or understanding medical information is a common reason for readmissions. Teachback is a proven tool for improving patient understanding. Who can use it? — Everyone who explains anything to a patient or family. When can I use it? — Use early in the months prior to a full-blown episode. Often, these symptoms are the same before each episode for an individual patient and are likely to include changes in sleep, activity level, and impulsivity.FAV, SMI Help patients recognize these symptoms and act to prevent relapse. Patients who develop strategies to handle prodromal symptoms are less likely to relapse.LAM Educate family members about prodromal symptoms; they often notice these changes before the patient is aware of them. care process and at each decision point or transition, especially when families or caregivers are present. Make sure caregivers participate in the Teach-back process to ensure they understand key information. • The effects of substance use and abuse. Alcohol and illegal drug use can What are the Steps? • The importance of treatment adherence. Treatment adherence is improved by 1.Explain or demonstrate a concept, using simple lay language. Tips: Avoid covering too much at one time — explain no more than 2 or 3 concepts at a time. Slow down and take pauses. If you’re giving the patient printed information, mark or highlight key areas of the handout or booklet as you explain. 2.Ask the patient/caregiver to repeat the information in their own words or demonstrate the process. Tips: Own the responsibility (“I want to see whether I explained this well”). Ask the patient to tell you how he or she would explain the information to a spouse or family member. Avoid yes/no questions. 3.Identify and correct misunderstandings. Tips: Show empathy and caring as you correct. Avoid making the patient feel they’ve failed a “test.” Don’t repeat the entire explanation or demonstration again unless it’s necessary — just focus on areas that need clarification. 4.Ask the patient/caregiver to explain or demonstrate again, to show improved understanding. Tips: Own the process again. “Let’s see if I cleared that up.” Avoid yes/no questions (such as “do you understand now?”). lead to more frequent relapse, poor response to lithium, and a more severe course of illness. Even limited use of alcohol or marijuana can destabilize this illness. Educate patients who use or abuse substances on how and where to get help. a better understanding of this illness, its course, and likelihood of relapse. During times of normal mood or hypomania, patients may not perceive themselves as being sick or needing treatment. Encourage patients to stick to the medication schedule even when they are feeling well. Medication side effects may also lead to poor treatment adherence. Teach patients to recognize and report side effects so medications can be adjusted. • The role of stress. Patients who understand the link between stress and symptom recurrence and then learn strategies for coping with stressful events may be able to reduce the impact stress has on the onset of mania and depression. Research indicates that many patients with bipolar disorder suffer from recurring symptoms after stressful life events that affect one’s ability to attain goals.JOH Additionally, there is an association between recurrent episode onset and patients who have experienced childhood physical, sexual, or emotional abuse.GIL • The connection between sleep and episode severity. It is important to help patients understand that the amount of sleep they get and the regularity of their sleep patterns translates to less severe symptoms of both mania and depression. Results from a study of concurrent and prospective associations from the National Institute of Mental Health Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) trial indicated an association between shorter total sleep time and increased mania severity as well as an association between greater sleep variability and increased mania and depression severity over 12 months.GRU 5.Continue this loop until you’re convinced the patient/caregiver understands the concept. Tips: Be patient — this process is worth the time it takes. Continue to be gracious in the process — patients can worry about judgment or wasting your time. 28 ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. MARCH 2016 MANAGEMENT OF BIPOL AR DISORDER RESOURCES AND REFERENCES Intermountain patient resources Clinicians can order Intermountain patient education booklets and fact sheets for distribution to their patients from Intermountain’s Online Library and Print Store, iprintstore.org. Call 801-442-3186 for ordering information. Choose from an array of booklets, trackers, and forms to help, including: Mental Health Integration Mood Disorder Questionnaire (MDQ) Today’s Date: Adult (page 1 of 1) Patient’s Name: Date of Birth: YES NO … you felt so good or so hyper that other people thought you were not your normal self, or you were so hyper that you got into trouble? … you were so irritable that you shouted at people or started fights or arguments? … you felt much more self-confident than usual? 1 Has there ever been a period of time when you were not your usual self and… • PHQ-9 Today’sslow Date: … thoughts raced through your head or you couldn’t your mind down? Patient’s Name: Areyou youthat currently: on medication for depression? … you were so easily distracted by things around you had trouble concentrating or staying on track? Over the last 2 weeks, how often have you been bothered by any of the following problems? not sure? Not at all Several days More than half the days Nearly every day 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 watching television 3 During the period of time indicated above, do you thinkorany of these symptoms were brought on 0 1 2 3 thebeing opposite — to being so having fidgety family, or restless that or youlegal havetroubles; been or 4 How much of a problem did any of these cause you —orlike unable work; money, 0 1 2 3 0 1 2 3 getting into arguments or fights? no problem 7. Trouble concentrating on things, such as reading the newspaper by prescription or other drugs? minor problem 8. Moving or speaking so slowly that other people could have noticed, 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 has affected your ability to function at work, home, or school) 4 Severe: Completely unable to function or hospitalized 3 Moderate to High: Great difficulty functioning 2 Moderate: Some difficulty functioning 1 Mild: Usual routine not affected much; may be more active than usual 0 Stable mood: no mania or depression 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 1 Mild: Usual routine not affected much; depressed mood 2 Moderate: Some difficulty functioning 3 Moderate to high: Great difficulty functioning 4 Severe: Completely unable to function or hospitalized 3. RECORD OTHER HABITS AND EVENTS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 # hours slept last night moving around a lot more than usual 9. Thoughts that you would be better off dead or of hurting yourself inmoderate serious problem some wayproblem DATES 1 # pills/day 2. CHART YOUR MOOD ( your mood each day and how it 2 If you checked YES to more than one of the above, haveyourself severalorofyour these everdown happened during family the same period of time? Pill strength in counseling? 3. Trouble falling/staying asleep, sleeping too much … you were much more interested in sex than usual? 6. Feeling bad about yourself — or that you’re a failure or have let Mood Tracking Chart Year: 1. CHART YOUR MEDS (record number of pills each day) Name of medication … you did things that were unusual for you or that other people might have thought were 4. Feeling tired or having little energy excessive, foolish, or risky? Month: Date of Birth: not on medication for depression? Adult (page 1 of 1) … you were much more social or outgoing than usual; for example, you telephoned friends 2. Feeling down, depressed, or hopeless in the middle of the night? 5. Poor appetite or overeating … spending money got you or your family into trouble? • Daily Little interest or pleasure in doing things … you were much more active or did many more1.things than usual? … you had much more energy than usual? • MDQ Daily Mood Tracking Chart Patient Health Questionnaire (PHQ-9) Total each column For Office Use Only: Used alcohol or drugs ( if yes – or enter number of drinks) Other symptoms or life events ( if yes; date and describe on back) Example symptoms: pain, paranoia, risky behaviors Example life events: argument, promotion, family conflict © 2007 Intermountain Healthcare. All rights reserved. Clinical Education Services 801.442.2963 IHCEDMH200 - 3/08 13 care of things at home, or get along with other people? How difficult have these problems made it for you to do your work,/take Reprinted with permission from the American Journal of Psychiatry, (Copyright 2000). American Psychiatric Association. A. Not ©2004–2014 Intermountain Healthcare. All rights reserved. Patient and Provider Publications 801-442-2963 MHI019 - 10/14 *50402* difficult at all Somewhat difficult Very difficult *50179* Patient Name: … you were much more talkative or spoke much faster than usual? Directions: At the end of each day, use this calendar to record your medications, overall mood, hours of sleep, and other symptoms and/or life events. This will help you and your healthcare provider monitor and improve your treatment. Mental Health Integration … you got much less sleep than usual and found you didn’t really miss it? Mania Disorder Information for Patients and families Depression • Bipolar Trc 50179 Extremely difficult MHI Pack 50402 B. In the past 2 years, have you felt depressed or sad most days, even if you felt okay sometimes? YES NO Comments: For Office Use Only: Symptom score (total # of answers in shaded areas): Severity score (total all points from all questions): *50408* PHQ 50408 The PHQ-9, copyright ©1999 by Pfizer Inc., is now in the public domain. PRIME-MD® and PRIME MD TODAY® are trademarks of Pfizer Inc. ©2004–2014 Intermountain Healthcare. All rights reserved. Patient and Provider Publications 801-442-2963 DEP601 - 10/14 Provider resources To find this CPM, clinicians can go to intermountain.net/clinical/Pages/All-Care-Process-Models-(CPMs).aspx, and select “Behavioral Health” from the topic list on the screen (as indicated below). ©2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. 29 MANAGEMENT OF BIPOL AR DISORDER References ADA American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. 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CPM DEVELOPMENT TEAM Mark Foote, MD Christopher Rich, MD Richard Arbogast, MD Carolyn Tometich, APRN Nathan Parent, PharmD Richard Martini, MD Shannon Saldana, MD George Nikopoulos, MD Sam Weber, MD This CPM presents a model of best care based on the best available scientific evidence at the time of publication. It is not a prescription for every physician or every patient, nor does it replace clinical judgment. All statements, protocols, and recommendations herein are viewed as transitory and iterative. Although physicians are encouraged to follow the CPM to help focus on and measure quality, deviations are a means for discovering improvements in patient care and expanding the knowledge base. Send feedback to Mark Foote, MD, Intermountain Healthcare, Medical Director Behavioral Health ([email protected]) or Carolyn Tometich, APRN, Intermountain Healthcare, Behavioral Health Operations Director ([email protected]). 32 ©2007–2016 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. Patient and Provider Publications CPM004 - 03/16 (minor changes 10/16)