Download The NICE guideline

Treating Depression in
Primary Care
Strengths & Weaknesses of the NICE guideline
David Goldberg
Institute of Psychiatry
King’s College, London
Evidence-based Medicine
 How good is the evidence that, for the
average person, medical treatment is better
than a placebo?
Evidence-based Medicine
 How good is the evidence that, for the
average person, medical treatment is better
than a placebo?
If there are several treatments:
 What is the most cost-effective treatment
for a particular condition, for an average
person?
Evidence-based Medicine
 How good is the evidence that, for the
average person, medical treatment is better
than a placebo?
If there are several treatments:
 What is the most cost-effective treatment
for a particular condition, for an average
person?
EBM is based upon meta-analyses of published
RCTs
Patient-based Evidence
What is the best treatment for me,
with my particular characteristics and
idiosyncrasies?
Patient-based Evidence
What is the best treatment for me,
with my particular characteristics and
idiosyncrasies?
To respond to this, the clinician needs
to know the evidence from RCTs, but to
be prepared to apply it to this
particular individual
Problems with RCTs of
depression
 In the USA, investigators often
advertise for “patients” in newspapers,
and pay for their co-operation
Problems with RCTs of
depression
 In the USA, investigators often
advertise for “patients” in newspapers,
and pay for their co-operation
 It is most unlikely that a clinician will
ask a severely depressed patient to
have a 50% chance of a placebo
Problems with RCTs of
depression
 In the USA, investigators often
advertise for “patients” in newspapers,
and pay for their co-operation
 It is most unlikely that a clinician will
ask a severely depressed patient to
have a 50% chance of a placebo
 although we may produce single
severity scores using say, the Hamilton
– how homogeneous are the patients?
Problems with RCTs of
depression
 In the USA, investigators often advertise
for “patients” in newspapers, and pay for
their co-operation
 It is most unlikely that a clinician will ask a
severely depressed patient to have a 50%
chance of a placebo
 although we may produce single severity
scores using say, the Hamilton – how
homogeneous are the patients?
 If many negative studies have been
suppressed, what does it mean to do metaanalyses on positively selected studies?
Emperor’s New Drugs
Kirsch et al 2002
Relying on RCTs registered with the FDA:
 Differences between AD and PBO only 2
symptoms on Ham-D
 Such small differences can produce large
“% responded “ differences
 Argues that such small differences are
due to side effects of ADs
Severity at baseline and response (-50%)
after 4 weeks´ treatment: Angst
placebo, moclobemide, imipramine
Irving Kirsch’s figure:
14
Improvement
12
10
8
6
4
2
0
15
17
19
21
23
25
Baseline HRSD
Linear (Drug)
Poly. (Placebo)
27
29
How homogeneous?
Consider 2 young unmarried female patients;
both aged 18; both with a Ham-D score of 24
How reasonable is it to try to say
everything about severity with a
single score on a depression scale?
Consider 2 young unmarried female patients;
both aged 18; both with a Ham-D score of 24
Patient 1: is a lone
mother
Parents divorced
Mother was depressed
Sexual abuse since aet
11
Left home aet 14
Casual sex since
Depressed for 2 years
Recently worse since
child taken into care
Consider 2 young unmarried female patients;
both aged 18; both with a Ham-D score of 24
Patient 1: is a lone
mother
Parents divorced
Mother was depressed
Sexual abuse since aet
11
Left home aet 14
Casual sex since
Patient 2: university student
Supportive parents
No FH of depression
Many friends
Affair with boyfriend last 2
years
Depressed for 2 years
He recently left with another
girl
Recently worse since
child taken into care
Depressed for 2 weeks since
he left
Will these two young women respond
in the same way to treatment?
Should the treatment be the same?
NICE:
The National Institute for
Clinical Excellence
A government provider of information
based on Evidence Based Medicine
(EBM) for the benefit of clinicians
and their patients.
Guidelines on schizophrenia, eating
disorders, anxiety disorders, selfharm and now - depression
NICE: Terms of Reference
 Clean meta-analyses to be performed
 Exclusions: <16; puerperal; physical illness
 Outcome: efficacy x3, tolerability, toxicity
 Economic considerations to be included
 Outputs: long document on net, text & tables;
short form; a very short form, User’s form
User Involvement
 3 Users on main group
 1 on each of 3 subgroups: services, drug
treatments, psychological treatments
 Gave their approval at every stage
 Told us now big a change in symptoms
was “worthwhile”
 Thus: “Statistically but not clinically
significant”
The NICE scale
A = Systematic reviews, RCT ‘s
B = 1+ Well conducted study
C = Opinions of ‘respected experts’: but
capable of empirical investigation
GPP = Our opinions of good practice
“Stepped Care”
Who needs treatment?
Who should give it?
When should patients be referred?
“Stepped Care”
The strict EBM approach:
Which patients merit active
treatment?
Which treatments for depression
should be available in primary care,
which in specialist care?
Who should give them?
- assumes a severity score gives comparable
information about depression
“Stepped Care”
Patient-based evidence:
Which individuals merit active
treatments?
Which particular treatments will suit
this individual?
When should this person be referred?
Evidence from EBM should be obeyed in
perhaps only 70% of cases
Who is responsible for
care?
What do they do?
Why do they
do it?
Acute Wards
CMHT, OPD, crisis
team, Day Hospital
PCMHW, GP, Counsellor,
social worker, psychologist
GP, Practice nurse,
Practice counsellor
Risk to Life
Treatment resistance
frequent recurrences
Moderate or Severe
Depression
Mild Depression
Recognition
Medication,ECT
nursing care
Medication, complex
Psychological i.v’s
Medication,Brief psych.
interventions, support groups
Active Review: Self Help,
Computerised CBT, Exercise
Step 1: Recognition in Primary
care & general hospital care
Screening with 2 routine questions
in high risk groups
[B]
OR
 past history of depression
 significant physical illness
causing disability
 other mental health problems
e.g. dementia
Use two screening questions..
- During the past month, have you been
feeling down, depressed or hopeless?
- During the last month, have you often
been bothered by having little interest or
pleasure in doing things
Consider psychological, social & physical
of the patient, and the quality of
interpersonal characteristics, & assess
impact on:
 Depression
 Choice of treatment [consider
alternatives, respect patient preference]
 Monitoring
RISK
 always ask directly about suicidal ideas
& intent, advise patients & carers to be
vigilant
GPP
 patients under 30 prescribed SSRIs
must be warned of suicidal ideas, and
seen again a week later
C
 ensure that suicidal patients have
adequate social support
GPP
Information
 provide appropriate information on
nature, course and treatment of
depression
GPP
 avoid use of clinical language & provide
information in language understood by
the patient
GPP
 make contact with those who do not
attend follow-up
C
RECOGNISED, MILD DEPRESSION
 Patients may improve spontaneously
 where intervention is not wanted, arrange
further consultation within 2 weeks
 contact patients who do not attend
 consider advice about sleep hygiene and
physical exercise [3+ sessions /week; >45mins
for 12 weeks]
 consider guided self help or written support
materials
 computerised treatments may also help
Step 2: Recognised mild
depression
The following are all recommended:
• physical exercise
[B]
• problem solving
[B]
• guided self-help
[A]
• Computerised CBT
[A]
• “watchful waiting”
[GPP]
• St. John’s Wort (with reservations!) [B]
• AD’s not recommended for initial Rx of
mild or sub-threshold depression
[C]
So, is the criterion for
“Major Depression” too low?
PROBABLY NOT:
 Clinicians should take account of time course,
family & previous history, availability of social
support as well as “severity” on a symptom scale
 they should offer alternative treatments as well
as, and sometimes instead of, drugs
 Some ADs have other effects than mood elevation,
including anxiolytic & hypnotic effects, which can
be extremely useful
 Anything that encourages a “clinical management”
approach is desirable
 it is the clinician who must appear in the Coroner’s
Court!
Self-help vs. waiting list
Mead et al Psych Med 2005, 35, 1633
114 patients with anxious depression
randomised to self-help (home-made) and
waiting list.
No diagnostic measure, but Beck DI = 26 at
onset
3 month FU – no differences in outcome in
either depression or anxiety; BDI = 17-20
Step 3: Moderate & severe
depression
 Active treatment recommended in
all cases
 Offer anti-depressants in all
cases, but discuss fears about
addiction
 Monitor patients for side effects
& suicidal ideas regularly
 continue AD’s for 6/12+ after
remission
Psychological treatments
Problem solving by PC staff
[B]
If psychological treatment preferred,
CBT is Rx of choice [16-20 sessions
over 6-9 months + consider boosters]
[A]
Antidepressants compared
 In general practice, they all have equal
efficacy
 Some are better tolerated than
others
 Some are more toxic in over-dose
 females tolerate tricyclics poorly
 They have very different costs!
Some relative costs….
For drugs, assume 4 sessions, 10 mins
Amitryptiline 100mg……..…….. £ 67.10
Fluoxetin 20mg………………….. £114.00
Venlafaxine 75mg……………
£159.50
 Problem solving, 6 x 30 mins
 By GP …………………………
£273.00
 By nurse………..……………
£183.00
Drug treatments in PC
First line treatment
 SSRI’s are 1st line AD’s, more so for women
[A]
 Continue treatment for 6/12
[A]
 Fluoxetine & citalopram cheap, fewest
discontinuation symptoms of SSRIs [C]
 sertraline is best in heart disease [GPP]
 Do not use venlafaxine as 1st line Rx [B]
 Avoid paroxetine, short ½ life
[C]
 Avoid dothiepin in isch.ht.disease [C]
Drug treatments in PC
The patient fails to respond…
 check drug taken regularly & in
prescribed dose
 increase dose within permitted range,
only modest, incremental increases
 if poorly tolerated switch to another
drug
 switch to 2nd AD if no response in 1/12
Drug treatments in PC
Second line treatments
 Try another SSRI
[C]
 Mirtazepine acceptable (but sedation & weight gain)
[A]
 Moclobemide acceptable (but wash out previous AD)
[A]
 Lofepramine, mirtazepine & reboxetine are safer in
o/d
[GPP]
 Combined treatments, lithium augmentation,
phenelzine, and venlafaxine, should not be initiated in
PC
Chronic anxious depression
(mainly seen in primary care)
Remember social & I-P causes
[GPP]
Combined AD and CBT
[A]
Consider befriending
[C]
Telephone support
[B]
Enhanced care
[C]
Enhanced care
Vonkorff & Goldberg BMJ 2001, 323, 948
Intensive follow up, by nurse, producing better
outcomes at moderate cost
Enhanced care
Vonkorff & Goldberg BMJ 2001, 323, 948
Intensive follow up, by nurse, producing better
outcomes at moderate cost
Vergouwen et al, Psychol Med 2005, 35,25:
Randomised 211 depressed PC pts of 30 GPs to
“depression care programme DCP + SSRI” or just SSRI.
Results: Adherence high (87% in both groups at 10/52),
all symptom measures = at all FU points. Both groups had
systematic follow-up; DCP had “patient education, self
help, active participation of Dr & pt in treatment”
How to decide in each case?
(Patient-based Evidence)
What is time course of the disorder?
Is there a family history of depression?
Is there a past history of depression?
Is there social support?
How severe is the depression now?
Is severity increasing?
How to decide in each case?
(Patient-based Evidence)
What is time course of the disorder?
Less than 2 weeks, or
Symptoms intermittent
- general advice, watch & wait
How to decide in each case?
What is time course of the disorder?
Is there a family history of depression?
If YES, favours active treatment
How to decide in each case?
What is time course of the disorder?
Is there a family history of depression?
Is there a past history of depression?
If YES, favours active treatment
How to decide in each case?
What is time course of the disorder?
Is there a family history of depression?
Is there a past history of depression?
Is there good social support?
NO – active treatment
YES, and MILD:
favours advice, watch & wait
How to decide in each case?
What is time course of the disorder?
Is there a family history of depression?
Is there a past history of depression?
Is there social support?
How severe is the depression now?
Is severity increasing?
≥7 symptoms or ≤ 6 deteriorating: treat
≤6, improving - advice, watch & wait
Who is responsible for
care?
What do they do?
Why do they
do it?
Acute Wards
CMHT, OPD, crisis
team, Day Hospital
PCMHW, GP, Counsellor,
social worker, psychologist
GP, Practice nurse,
Practice counsellor
Risk to Life
Treatment resistance
frequent recurrences
Moderate or Severe
Depression
Mild Depression
Recognition
Medication,ECT
nursing care
Medication, complex
Psychological i.v’s
Medication,Brief psych.
interventions, support groups
Active Review: Self Help,
Computerised CBT, Exercise
Who should be referred to
mental health care?
 all those who ask to be referred
 all new cases of psychosis, and all who relapse
on treatment
 cases of severe eating disorders
 all those whose depression fails to respond to
two different treatments, or who relapse
frequently
 all cases where risk of suicide is high, or
there is a risk to others
 others who require a specialist treatment not
available in primary care: eg CBT, or sexual
counselling, ECT
The UK Model
New problems that fail to respond
to treatment, old patients in
relapse
PRIMARY
CARE
COMMUNITY
MENTAL HEALTH
TEAM
CMHC staff visit chronic patients, liaise with GP;
stable patients in remission sent back to primary care
SHARED CARE PLANS HERE
Who should be referred back
for MH to primary care?
“Shared Care”
 all those who have stabilised on
treatment – for example schizophrenics
and bipolar illnesses.
 all those chronic depressives for whom
a management programme has been
agreed.
SHARED CARE:
Shared care refers to improving the
relationship between primary and
secondary services, with
 shared care plans, mutually agreed
 a dedicated linkworker
 mild cases may only see psychiatrist,
more severe cases also have nursing
care
A Shared Care Plan








name,address, next of kin
name of key worker, phone
diagnosis, treatment plan
main symptoms in relapse
main symptoms in remission
current treatment, who
gives
best alternative treatment
how to admit in emergency,
phone number!
Joe Neary (GP):
In “Primary Solutions” Sainsbury 2003
“…joint working needs to be agreed
between the community mental
health team and the primary care
team, but such practice is
uncommon….both services are
overloaded, and both have daunting
quality and development agendas”
Step 4: ROLE OF SPECIALIST
MENTAL HEALTH SERVICES
Separate advice on
 “acute phase non-responders”
 treatment resistant cases
 relapse prevention
 atypical cases
Acute Phase non-responders
 Augment with another class AD
(but not
[B]
 Move to CBT or IPT
[B]
 If severe, drug + CBT
[B]
 venlafaxine may help, but toxicity in
overdose
[B]
 Augmenting with lithium “could” help
[C]
 Cardiac disease: sertraline, not prothiaden
[B]
carbamazepine, lamotrigine or buspirone)
Treatment Resistant
[failed to respond to 2+ AD’s]
 Moderate+, no response to AD’s -> CBT
[B]
 Partial response to AD’s, add CBT
[B]
 Augmentation strategy: AD + AD
[B]
 Go on to venlafaxine
[C]
 Adding Lithium “should” help
Relapse prevention
 Multiple episodes, good response continue
treatment for 2+ yrs
[B]
 Augment AD with lithium
[B]
 If lithium augmentation effective, maintain
for 6/12+
[B]
 If unable or unwilling to continue an effective
drug -> IPT
[B]
 Crisis resolution and home treatment teams
[C]
Atypical Cases
 Atypical depression in females: MAOI’s
if SSRIs fail
[B]
 Psychotic depression: augment with
anti-psychotic
[C]
Cognitive behaviour therapy
 for those who fail medical treatments
 with history of relapse / limited
response to other measures
 those at risk of relapse who do not
wish to continue drugs
 those with 2+ previous episodes of
moderate or severe depression
Step 5: In-patient care
Admit if significant risk of suicide or self
harm
[C]
Consider crisis resolution and home
treatment teams for those who can be
discharged early
[C]
ECT if rapid or short-term improvement is
called for in severe depression
[NICE]
Conclusion - 1
We need to know about EBM, for
the average patient
But we have to have some way of
applying it to the patient consulting
us
Conclusion - 2
Drugs working on different pharmacological
systems are equally effective
Psychotherapies working on quite different
principles are almost equally effective
Caring treatment and a placebo is fairly
effective
But ALL patients need to have hope, and an
expectancy of improvement
Conclusion - 3
We all have our own ways of
achieving this end!
Download our Report from the Internet:
www.nice.org.uk/pdf/word/CG023NICEguideline.
doc
(All appendices can also be downloaded from the
NICE site)
Obtain hard copy: National Collaborating Centre
for Mental Health (2004) “Depression:
Management of depression in primary and
secondary care” London: Gaskell, or from NICE