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Guidelines for the pharmacological treatment of post traumatic stress disorder Document name: Post Traumatic Stress Disorder: Guidelines for pharmacological treatment Portfolio Document type: Medicines Management Guideline Staff group to whom it applies: All prescribers, pharmacy and clinical staff within the Trust Distribution: The whole Trust How to access: Intranet Issue date: Version 2 March 2012 Next review: February 2015 Approved by: Drug and Therapeutics Sub Committee Developed by: Kate Dewhirst, Deputy Chief Pharmacist Director leads: Medical Director Contact for advice: [email protected] South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 1 Guidelines for the pharmacological treatment of post traumatic stress disorder CONTENTS Page 3 1. Treatment algorithm …………………………………..……………………… 2. Introduction……………………………………………….…………………… 4 3. General principles……………………………………………………………… 5 4. Medication ……………………………………………………………………… 6 5. References and further reading………….…………………………………… 7 Appendix 1: Antidepressant discontinuation/withdrawal symptoms Appendix 2: Committee on Safety of Medicines (CSM) and Medicines and Healthcare Regulatory Authority (MHRA) Advice 8 9 Author Kate Dewhirst, Deputy Chief Pharmacist Abbreviations NICE PTSD SSRI TCAs CSM MHRA CBT National Institute for Health and Clinical Excellence Post Traumatic Stress Disorder Selective serotonin re-uptake inhibitors Tricyclic antidepressants Committee on Safety of Medicines Medicines and Healthcare Regulatory Authority Cognitive behavioural therapy South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 2 Guidelines for the pharmacological treatment of post traumatic stress disorder 1. TREATMENT ALGORITHM Pharmacological Treatment of Post Traumatic Stress Disorder Diagnosis of PTSD Treatment of choice is traumafocused psychological therapy (e.g. CBT) Consider prescribing medication only in adults (children should be offered trauma-focused psychological treatment) if the individual prefers not to engage in trauma-focused psychological treatment if the individual cannot start psychological treatment because of the serious threat of further trauma if the individual has gained little or no benefit from a course of trauma-focused psychological treatment as an adjunct to psychological treatment where there is significant co-morbid depression or severe hyperarousal that significantly affects the individual’s ability to benefit from psychological treatment *Discuss ●Potential side effects including transient anxiety ●Delay in onset of effect ●Length of treatment ●License implications ●Potential discontinuation or withdrawal symptoms Provide ●Written information Prescribe low initial doses and gradually increase The largest evidence base exists for paroxetine, sertraline See Appendix 2 -CSM advice Prescribe an SSRI* Consider the short-term prescription of a hypnotic medication Monitor ●One week after starting treatment in those with PTSD who are at risk of selfharm or suicide or are aged between 18 and 29 years ●Two weeks after starting treatment in others. ●See at regular and appropriate intervals thereafter throughout treatment Assess response at 8 to 12 weeks Partial response Response Continue treatment for 12 months then gradually withdraw. See appendix 1 Little or no response Consider gradual increase in dose within approved limits Monitor and assess as above South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD Switch to an antidepressant of a different class Mirtazepine Amitriptyline or Phenelzeine (NICE recommend specialist mental health care supervision) Monitor and assess as above Adjunctive treatment with olanzapine may be considered in refractory cases 3 Guidelines for the pharmacological treatment of post traumatic stress disorder 2. INTRODUCTION NICE published clinical guidelines for the management of post traumatic stress disorder (PTSD) in adults and children in primary and secondary care in March 2005. This document will concentrate on the pharmacological treatment options. Recommended first line treatment options are non-pharmacological and include psychological therapies such as trauma focused cognitive behavioural therapy (CBT) and eye movement desensitisation and reprocessing. Pharmacological treatments are recommended for adults only. For information on psychological treatments refer to the NICE guideline or the local Psychological Services Department PTSD can affect anyone of any age who experiences, witnesses or is confronted with an event or events that involved actual or threatened death or serious injury, or the threat to the physical integrity of self or others. Prevalence has been estimated between 1-9% and carries significant personal and social costs. Many of those diagnosed have a co-morbid condition such as depression, generalised anxiety states substance misuse. There is significant overlap of symptoms of depression and anxiety, such as reduced concentration levels and sleep disturbances. Symptoms may develop immediately after the traumatic event or less commonly have a delayed onset and may include Re-experiencing through flashbacks or nightmares Avoidance of people or situations Hyperarousal leading to sleep problems, irritability hypervigilance Emotional numbing detachment from other people, amnesia Depression Alcohol or substance misuse Anger Somatic symptoms Pharmacological treatment is based on the hypothesis that severe trauma can lead to long lasting neurobiological changes particularly within the serotonin system. South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 4 Guidelines for the pharmacological treatment of post traumatic stress disorder 3. GENERAL PRINCIPLES The choice of treatment should be shared between the service user and the healthcare professionals. This improves concordance and clinical outcomes. Consider service user preference, experience and outcomes of previous treatments. Do not routinely prescribe medication for treatment of PTSD for children and adolescents. Be alert to co-morbidity, which is common (particularly anxiety, depression and substance misuse). It may be appropriate to treat any co-morbid substance misuse before beginning the treatment for PTSD. Consider NICE recommendations and licensed indications when choosing treatment options. Many of the trials assessed in NICE have statistically significant results but clinical significance is inconclusive. Personal history, any self-medication, cultural and individual characteristics are important considerations in care. Initial treatment and assessment should be offered in primary care. Sufficient information written and verbal should be provided to the service user and carer about treatment options. In particular, for adults prescribed antidepressants, discuss the potential side effects and discontinuation /withdrawal symptoms, especially for paroxetine (See appendix 1). Where appropriate the Care Program Approach may be used and is particularly useful where care is shared between primary and secondary care. Start with low initial doses. Doses of SSRIs should be started low (e.g. paroxetine 10mg per day) and increased gradually to reduce the risks of initial exacerbation of anxiety symptoms. Doses higher than those used in depression may be required to achieve full effect. Increases should be gradual and within approved limits. Increasing the dose in the presence of agitation or restlessness, particularly at the beginning of treatment may be detrimental. Response to treatment may take 8 to 12 weeks. Treatment should be continued for at least 12 months after resolution of symptoms followed by a gradual reduction. If response to the first medication is poor a different class of antidepressant should be used. Apply the same monitoring precautions regarding increased risk of anxiety, suicidal ideation and akathesia in the initial stages of treatment with antidepressants as those recommended in depression and anxiety. See service users one week after commencing treatment and thereafter at frequent, regular and appropriate intervals throughout treatment. South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 5 Guidelines for the pharmacological treatment of post traumatic stress disorder 4. MEDICATION Drug SSRIs Paroxetine Licensed for post traumatic stress disorder Sertraline Licensed for post traumatic stress disorder in adult females Potential Advantages Low toxicity in overdose Less sedative than other antidepressants Less anticholinergic side effects than TCA Some supporting evidence for paroxetine and sertraline Tricyclic antidepressants Amitriptyline Imipramine Delayed onset of effects Exacerbation of symptoms in early stages. Withdrawal/discontinuation symptoms (more reports for paroxetine than other SSRIs) Evidence is often inconclusive SSRIs Fluoxetine Not licensed Mirtazepine Potential Disadvantages Costs per 28 days supply Drug Tariff March 2012 Paroxetine 20mg once a day £2.10 Sertraline 50mg once a day £4.24 Fluoxetine 20mg once a day £0.95 Higher doses may be required e.g. fluoxetine 60mg per day (£48.52if 60mg capsules used) Sedative, may help with nightmares and sleep disturbance Limited supporting evidence Not licensed Sedative Weight gain Evidence is often inconclusive Mirtazepine 30mg once a day £1.77 Some supporting evidence for efficacy Sedative Not licensed Evidence is often inconclusive Anticholinergic side effects including constipation dry mouth and blurred vision Sedative High doses up to 300mg per day may be needed, potential cardiac side effects, ECG recommended Cardiotoxic in overdose Not licensed Food and dietary interactions with potential hypertensive crisis Long-term efficacy not established. Tolerance and dependence if used long term Not Licensed. No evidence of efficacy, sedative and high risk of side effects compared to benefits Amitriptyline 150mg a day £2.81 (based on 50mg tablets) Phenelzine Some supporting evidence May help intrusive and avoidance symptoms Hypnotics Short term sleep improvement Antipsychotics Limited supporting evidence for olanzapine as adjunct to SSRIs in those unresponsive to SSRIs alone South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD (BNF 62) Imipramine 150mg a day £7.26 (based on 25mg tablets) Phenelzine 15mg three times a day £15.75 Olanzapine 10mg per day £8.81 6 Guidelines for the pharmacological treatment of post traumatic stress disorder 5. REFERENCES AND FURTHER READING 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. NICE Clinical Guideline 26. The management of post-traumatic stress disorder in adults and children in primary and secondary care. March 2005 Post Traumatic stress disorder. Clinical Evidence February 2010 www.clinicalevidence.bmj.com Medicines and Healthcare Regulatory Authority/Committee on Safety of Medicines www.mhra.gov.uk Maudsley Prescribing Guidelines 2010 Psychotropic Drug Directory 2012 BNF www.bnf.org Summaries of Product Characteristics www.medicines.org.uk Phenelzine Shared Care Guideline, SWYPFT nww.swyt.nhs.uk Paroxetine communication, SWYPFT nww.swyt.nhs.uk Antidepressants in clinical practice: Guidelines for safe and effective use of antidepressants in adults and older people (in line with NICE Clinical Guideline 90). SWYPFT nww.swyt.nhs.uk Stein DJ et al. Pharmacology for post traumatic stress disorder (PTSD) (Review). The Cochrane Collaboration. 2009 The management of post traumatic stress disorder in adults. Clinical Resource Efficiency Support Team Northern Ireland. June 2003 South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 7 Guidelines for the pharmacological treatment of post traumatic stress disorder APPENDIX 1 DISCONTINUATION /WITHDRAWAL SYMPTOMS ASSOCIATE WITH ANTIDEPRESSANTS Stopping antidepressants abruptly can cause discontinuation/withdrawal symptoms. To minimize the risk of the dose should be reduced gradually over an extended period of time. Symptoms are usually mild and self-limiting but can occasionally be severe especially if the antidepressant is stopped abruptly. Some commonly experience withdrawal symptoms Flu-like symptoms (chills, aches, sweating) Nausea and vomiting Dizziness Numbness and tingling (electric shock sensations) Irritability Anxiety Insomnia Excessive (vivid) dreams Not all symptoms are associated with every antidepressant and may one individual experience not all. The perception of symptoms may be made worse if no prior warning is given. Symptoms of discontinuation may be misinterpreted as relapse of the original illness or a new physical illness. Onset is usually within 5 days of stopping, depending on the half-life of the antidepressant. If symptoms are mild, discussion of the reason for the symptoms and reassurance of the selflimiting nature are required. The service user should be monitored for resolution of the symptoms. If symptoms are severe the re-introduction of the antidepressant should be considered followed by a more gradual reduction. The use of another antidepressant from another class with a longer halflife may make reduction easier. Fluoxetine, having a longer plasma half-life, seems to be associated with a lower incidence of discontinuation symptoms than other similar antidepressants. South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 8 Guidelines for the pharmacological treatment of post traumatic stress disorder APPENDIX 2 Committee on Safety of Medicines (CSM) and Medicines and Healthcare Regulatory Authority (MHRA) Advice Hyponatraemia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants however it has been reported more frequently with SSRIs than with other antidepressants. The CSM has advised that hyponatraemia should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant. CSM advice (SSRIs for major depressive disorder in children and adolescents). Following a review of the safety and efficacy of SSRIs for the treatment of depression in children and adolescents the CSM has advised (December 2003) that the SSRIs citalopram, escitalopram, paroxetine and sertraline and the related antidepressant venlafaxine are contra-indicated in those under 18 years; fluvoxamine should also not be used to treat depression in these individuals because there is insufficient information on safety and efficacy. CSM advice (paroxetine dosage). The recommended dose for the treatment of depression, social anxiety disorder, generalised anxiety disorder, and post-traumatic stress disorder is 20mg and for obsessive-compulsive disorder and panic disorder it is 40mg daily. There is no evidence that higher doses are more effective. South West Yorkshire Partnership NHS Foundation Trust Pharmacological guidelines for the Treatment of PTSD 9