Treating Depression in Treating Depression in Primary CarePrimary Care
Strengths & Weaknesses of the NICE Strengths & Weaknesses of the NICE guidelineguideline
David GoldbergDavid Goldberg
Institute of PsychiatryInstitute of Psychiatry
King’s College, LondonKing’s College, London
Evidence-based MedicineEvidence-based Medicine How good is the evidence that, for the How good is the evidence that, for the
average person, medical treatment is average person, medical treatment is better than a placebo?better than a placebo?
Evidence-based MedicineEvidence-based Medicine How good is the evidence that, for the How good is the evidence that, for the
average person, medical treatment is average person, medical treatment is better than a placebo?better than a placebo?
If there are several treatments:If there are several treatments: What is the most cost-effective treatment What is the most cost-effective treatment
for a particular condition, for an average for a particular condition, for an average person?person?
Evidence-based MedicineEvidence-based Medicine How good is the evidence that, for the How good is the evidence that, for the
average person, medical treatment is average person, medical treatment is better than a placebo?better than a placebo?
If there are several treatments:If there are several treatments: What is the most cost-effective treatment What is the most cost-effective treatment
for a particular condition, for an average for a particular condition, for an average person?person?
EBM is based upon meta-analyses of EBM is based upon meta-analyses of published RCTspublished RCTs
Patient-based EvidencePatient-based Evidence
What is the best treatment for me, with my particular characteristics and idiosyncrasies?
Patient-based EvidencePatient-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 Problems with RCTs of depressiondepression
In the USA, investigators often In the USA, investigators often advertise for “patients” in advertise for “patients” in newspapers, and pay for their co-newspapers, and pay for their co-operationoperation
Problems with RCTs of Problems with RCTs of depressiondepression
In the USA, investigators often In the USA, investigators often advertise for “patients” in advertise for “patients” in newspapers, and pay for their co-newspapers, and pay for their co-operationoperation
It is most unlikely that a clinician will It is most unlikely that a clinician will ask a severely depressed patient to ask a severely depressed patient to have a 50% chance of a placebohave a 50% chance of a placebo
Problems with RCTs of Problems with RCTs of depressiondepression
In the USA, investigators often In the USA, investigators often advertise for “patients” in newspapers, advertise for “patients” in newspapers, and pay for their co-operationand pay for their co-operation
It is most unlikely that a clinician will It is most unlikely that a clinician will ask a severely depressed patient to ask a severely depressed patient to have a 50% chance of a placebohave a 50% chance of a placebo
although we may produce single although we may produce single severity scores using say, the Hamilton severity scores using say, the Hamilton – how homogeneous are the patients?– how homogeneous are the patients?
Problems with RCTs of Problems with RCTs of depressiondepression
In the USA, investigators often advertise for In the USA, investigators often advertise for “patients” in newspapers, and pay for their co-“patients” in newspapers, and pay for their co-operationoperation
It is most unlikely that a clinician will ask a It is most unlikely that a clinician will ask a severely depressed patient to have a 50% severely depressed patient to have a 50% chance of a placebochance of a placebo
although we may produce single severity although we may produce single severity scores using say, the Hamilton – how scores using say, the Hamilton – how homogeneous are the patients?homogeneous are the patients?
If many negative studies have been If many negative studies have been suppressed, what does it mean to do meta-suppressed, what does it mean to do meta-analyses on positively selected studies?analyses on positively selected studies?
Emperor’s New DrugsEmperor’s New DrugsKirsch et al 2002Kirsch 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:Irving Kirsch’s figure:
0
2
4
6
8
10
12
14
15 17 19 21 23 25 27 29
Baseline HRSD
Imp
rove
men
t
Linear (Drug) Poly. (Placebo)
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 24Patient 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 24Patient 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
Patient 2: university student
Supportive parents
No FH of depression
Many friends
Affair with boyfriend last 2 years
He recently left with another girl
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:NICE:The National Institute for The National Institute for
Clinical ExcellenceClinical 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, self-harm and now - depression
NICE: Terms of ReferenceNICE: Terms of Reference Clean meta-analyses to be performedClean meta-analyses to be performed
Exclusions: <16; puerperal; physical illnessExclusions: <16; puerperal; physical illness
Outcome: efficacy x3, tolerability, toxicityOutcome: efficacy x3, tolerability, toxicity
Economic considerations to be includedEconomic considerations to be included
Outputs: long document on net, text & Outputs: long document on net, text & tables; short form; a very short form, tables; short form; a very short form, User’s formUser’s form
User InvolvementUser Involvement
3 Users on main group3 Users on main group 1 on each of 3 subgroups: services, 1 on each of 3 subgroups: services,
drug treatments, psychological drug treatments, psychological treatmentstreatments
Gave their approval at every stageGave their approval at every stage Told us now big a change in Told us now big a change in
symptoms was “worthwhile”symptoms was “worthwhile” Thus: “Thus: “Statistically but not clinically Statistically but not clinically
significantsignificant””
The NICE scaleThe NICE scale
A = Systematic reviews, RCT ‘sA = Systematic reviews, RCT ‘s
B = 1+ Well conducted studyB = 1+ Well conducted study
C = Opinions of ‘respected experts’: C = Opinions of ‘respected experts’: but capable of empirical investigationbut capable of empirical investigation
GPP = Our opinions of good practiceGPP = Our opinions of good practice
““Stepped Care”Stepped Care”
Who needs treatment?
Who should give it?
When should patients be referred?
““Stepped Care”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
Who should give it?
When should patients be referred?
““Stepped Care”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
Recognition
Mild Depression
Moderate or Severe Depression
Treatment resistance frequent recurrences
Risk to Life
GP, Practice nurse, Practice counsellor
Active Review: Self Help, Computerised CBT, Exercise
PCMHW, GP, Counsellor, social worker, psychologist
Medication,Brief psych. interventions, support groups
CMHT, OPD, crisis team, Day Hospital
Medication, complexPsychological i.v’s
Acute Wards Medication,ECT nursing care
Who is responsible for care?
What do they do?
Why do they
do it?
Step 1: Recognition in Primary Step 1: Recognition in Primary care & general hospital carecare & 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 problemse.g. dementia
Use two screening Use two screening questions..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 & Consider psychological, social & physical of the patient, and the quality physical of the patient, and the quality
of interpersonal characteristics, & of interpersonal characteristics, & assess impact on:assess impact on:
DepressionDepression
Choice of treatment Choice of treatment [consider [consider alternatives, respect patient preference]alternatives, respect patient preference]
MonitoringMonitoring
RISKRISK
always ask directly about suicidal ideas always ask directly about suicidal ideas & intent, advise patients & carers to be & intent, advise patients & carers to be vigilantvigilant GPPGPP
patients under 30 prescribed SSRIs patients under 30 prescribed SSRIs mustmust be warned of suicidal ideas, and be warned of suicidal ideas, and seen again a week laterseen again a week later CC
ensure that suicidal patients have ensure that suicidal patients have adequate social supportadequate social support GPPGPP
InformationInformation
provide appropriate information on provide appropriate information on nature, course and treatment of nature, course and treatment of depressiondepression GPPGPP
avoid use of clinical language & provide avoid use of clinical language & provide information in language understood by information in language understood by the patientthe patient GPPGPP
make contact with those who do not make contact with those who do not attend follow-upattend follow-up CC
RECOGNISED, MILD DEPRESSIONRECOGNISED, MILD DEPRESSION
Patients may improve spontaneously Patients may improve spontaneously where intervention is not wanted, arrange where intervention is not wanted, arrange
further consultation within 2 weeksfurther consultation within 2 weeks contact patients who do not attendcontact patients who do not attend consider advice about consider advice about sleep hygienesleep hygiene and and
physical exercisephysical exercise [3+ sessions /week; [3+ sessions /week; >45mins for 12 weeks]>45mins for 12 weeks]
consider consider guided self helpguided self help or written or written support materialssupport materials
computerised treatmentscomputerised treatments may also help may also help
Step 2: Recognised mild Step 2: Recognised mild depressiondepression
The following are all recommended:The following are all recommended:• physical exercise physical exercise [B][B]• problem solving problem solving [B][B]• guided self-help guided self-help [A][A]• Computerised CBT Computerised CBT [A][A]• “ “watchful waiting” watchful waiting” [GPP][GPP]• St. John’s Wort St. John’s Wort (with reservations!) (with reservations!) [B][B]• AD’s not recommended for initial Rx AD’s not recommended for initial Rx of mild or sub-threshold depression of mild or sub-threshold depression
[C][C]
So, is the criterion for So, is the criterion for “Major Depression” too low?“Major Depression” too low?
Clinicians should take account of time course, Clinicians should take account of time course, family & previous history, availability of social family & previous history, availability of social support as well as “severity” on a symptom support as well as “severity” on a symptom scalescale
they should offer alternative treatments as they should offer alternative treatments as well as, and sometimes instead of, drugswell as, and sometimes instead of, drugs
Some ADs have other effects than mood Some ADs have other effects than mood elevation, including anxiolytic & hypnotic elevation, including anxiolytic & hypnotic effects, which can be extremely usefuleffects, which can be extremely useful
Anything that encourages a “clinical Anything that encourages a “clinical management” approach is desirablemanagement” approach is desirable
it is the clinician who must appear in the it is the clinician who must appear in the Coroner’s Court!Coroner’s Court!
PROBABLY NOT:
Self-help vs. waiting listSelf-help vs. waiting listMead et al Psych Med 2005, 35, 1633Mead 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 Step 3: Moderate & severe depressiondepression
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 treatmentsPsychological 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 comparedAntidepressants 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….Some relative costs….
For drugs, assume 4 sessions, 10 minsFor drugs, assume 4 sessions, 10 mins
Amitryptiline 100mg……..…….. £ 67.10Amitryptiline 100mg……..…….. £ 67.10
Fluoxetin 20mg………………….. £114.00Fluoxetin 20mg………………….. £114.00
Venlafaxine 75mg…………… £159.50Venlafaxine 75mg…………… £159.50 Problem solving, 6 x 30 minsProblem solving, 6 x 30 mins By GP ………………………… £273.00By GP ………………………… £273.00 By nurse………..…………… £183.00By nurse………..…………… £183.00
Drug treatments in PCDrug treatments in PCFirst line treatmentFirst line treatment
SSRI’s are 1SSRI’s are 1stst line AD’s, more so for women line AD’s, more so for women [A][A]
Continue treatment for 6/12Continue treatment for 6/12 [A][A] Fluoxetine & citalopram cheap, fewest Fluoxetine & citalopram cheap, fewest
discontinuation symptoms of SSRIsdiscontinuation symptoms of SSRIs [C][C] sertraline is best in heart disease sertraline is best in heart disease [GPP][GPP] Do not useDo not use venlafaxine as 1 venlafaxine as 1stst line Rx line Rx [B][B] AvoidAvoid paroxetine, short ½ life paroxetine, short ½ life [C][C] AvoidAvoid dothiepin in isch.ht.disease dothiepin in isch.ht.disease [C][C]
Drug treatments in PCDrug treatments in PCThe patient fails to respond…The patient fails to respond…
check drug taken regularly & in check drug taken regularly & in prescribed doseprescribed dose
increase dose within permitted range, increase dose within permitted range, only modest, incremental increasesonly modest, incremental increases
if poorly tolerated switch to another if poorly tolerated switch to another drugdrug
switch to 2switch to 2ndnd AD if no response in 1/12 AD if no response in 1/12
Drug treatments in PCDrug treatments in PCSecond line treatmentsSecond line treatments
Try another SSRITry another SSRI [C][C] Mirtazepine acceptable (but sedation & weight Mirtazepine acceptable (but sedation & weight
gain) gain) [A][A] Moclobemide acceptable (but wash out previous Moclobemide acceptable (but wash out previous
AD)AD) [A][A] Lofepramine, mirtazepine & reboxetine are safer Lofepramine, mirtazepine & reboxetine are safer
in o/din o/d [GPP] [GPP]
Combined treatments, lithium augmentation, Combined treatments, lithium augmentation, phenelzine, and venlafaxine, should phenelzine, and venlafaxine, should notnot be be initiated in PCinitiated in PC
Chronic anxious depressionChronic anxious depression(mainly seen in primary (mainly seen in primary
care)care)
Remember social & I-P causes [GPP]
Combined AD and CBT [A]
Consider befriending [C]
Telephone support [B]
Enhanced care [C]
Enhanced careEnhanced careVonkorff & Goldberg BMJ 2001, 323, 948Vonkorff & Goldberg BMJ 2001, 323, 948
Intensive follow up, by nurse, producing better outcomes at moderate cost
Enhanced careEnhanced careVonkorff & Goldberg BMJ 2001, 323, 948Vonkorff & 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?How to decide in each case? (Patient-based Evidence)(Patient-based Evidence)
What is time course of the disorder?What is time course of the disorder?
Is there a family history of Is there a family history of depression?depression?
Is there a past history of depression?Is there a past history of depression?
Is there social support? Is there social support?
How severe is the depression now?How severe is the depression now?
Is severity increasing?Is severity increasing?
How to decide in each case?How to decide in each case?(Patient-based Evidence)(Patient-based Evidence)
What is time course of the disorder?What is time course of the disorder?
Less than 2 weeks, or
Symptoms intermittent
- general advice, watch & wait
How to decide in each case?How to decide in each case?
What is time course of the disorder?What is time course of the disorder?
Is there a family history of Is there a family history of depression?depression?
If YES, favours active treatment
How to decide in each case?How to decide in each case?
What is time course of the disorder?What is time course of the disorder?
Is there a family history of Is there a family history of depression?depression?
Is there a past history of depression?Is there a past history of depression?
If YES, favours active treatment
How to decide in each case?How to decide in each case?
What is time course of the disorder?What is time course of the disorder?
Is there a family history of Is there a family history of depression?depression?
Is there a past history of depression?Is there a past history of depression?
Is there good social support? Is there good social support?
NO – active treatment
YES, and MILD:
favours advice, watch & wait
How to decide in each case?How to decide in each case?
What is time course of the disorder?What is time course of the disorder?
Is there a family history of Is there a family history of depression?depression?
Is there a past history of depression?Is there a past history of depression?
Is there social supportIs there social support? ?
How severe is the depression now?How severe is the depression now?
Is severity increasing?Is severity increasing?
≥7 symptoms or ≤ 6 deteriorating: treat
≤6, improving - advice, watch & wait
Recognition
Mild Depression
Moderate or Severe Depression
Treatment resistance frequent recurrences
Risk to Life
GP, Practice nurse, Practice counsellor
Active Review: Self Help, Computerised CBT, Exercise
PCMHW, GP, Counsellor, social worker, psychologist
Medication,Brief psych. interventions, support groups
CMHT, OPD, crisis team, Day Hospital
Medication, complexPsychological i.v’s
Acute Wards Medication,ECT nursing care
Who is responsible for care?
What do they do?
Why do they
do it?
Who should be referred to Who should be referred to mental health care?mental health care?
all those who ask to be referredall those who ask to be referred all all new cases of psychosis, and all who relapse cases of psychosis, and all who relapse
on treatmenton treatment cases of cases of severesevere eating disorders eating disorders all those whose depression fails to respond to all those whose depression fails to respond to
two different treatments, or who relapse two different treatments, or who relapse frequentlyfrequently
all cases where all cases where risk of suiciderisk of suicide is high, or there is high, or there is a is a risk to othersrisk to others
others who require a specialist treatment not others who require a specialist treatment not available in primary care: eg CBT, or sexual available in primary care: eg CBT, or sexual counselling, ECTcounselling, ECT
New problems that fail to respond to treatment, old patients in relapse
CMHC staff visit chronic patients, liaise with GP; stable patients in remission sent back to primary care
PRIMARY
CARE COMMUNITY
MENTAL HEALTH
TEAM
The UK Model
SHARED CARE PLANS HERE
Who should be referred Who should be referred back for MH to primary back for MH to primary
care?care? ““Shared Care”Shared Care”all those who have stabilised on all those who have stabilised on
treatment – for example treatment – for example schizophrenics and bipolar illnesses. schizophrenics and bipolar illnesses.
all those chronic depressives for all those chronic depressives for whom a management programme whom a management programme has been agreed.has been agreed.
SHARED CARE: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 PlanA Shared Care Plan name,address, next of kinname,address, next of kin name of key worker, phonename of key worker, phone diagnosis, diagnosis, treatment plantreatment plan main symptoms in relapsemain symptoms in relapse main symptoms in remissionmain symptoms in remission current treatment, who current treatment, who
givesgives best alternative treatmentbest alternative treatment how to admit in emergency, how to admit in emergency,
phone number!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 Step 4: ROLE OF SPECIALIST MENTAL HEALTH SERVICESMENTAL HEALTH SERVICES
Separate advice on
“acute phase non-responders”
treatment resistant cases
relapse prevention
atypical cases
Acute Phase non-respondersAcute Phase non-responders Augment with another class AD Augment with another class AD (but not (but not
carbamazepine, lamotrigine or buspirone)carbamazepine, lamotrigine or buspirone) [B][B] Move to CBT or IPTMove to CBT or IPT [B][B] If severe, drug + CBTIf severe, drug + CBT [B][B] venlafaxine may help, but toxicity in venlafaxine may help, but toxicity in
overdoseoverdose [B][B] Augmenting with lithium “could” helpAugmenting with lithium “could” help
[C][C] Cardiac disease: sertraline, not prothiaden Cardiac disease: sertraline, not prothiaden
[B][B]
Treatment ResistantTreatment Resistant[failed to respond to 2+ AD’s][failed to respond to 2+ AD’s]
Moderate+, no response to AD’s -> CBT Moderate+, no response to AD’s -> CBT [B][B]
Partial response to AD’s, add CBTPartial response to AD’s, add CBT [B][B] Augmentation strategy: AD + AD Augmentation strategy: AD + AD [B][B] Go on to venlafaxineGo on to venlafaxine
[C][C] Adding Lithium “should” helpAdding Lithium “should” help
[C][C]
Relapse preventionRelapse prevention
Multiple episodes, good response continue Multiple episodes, good response continue treatment for 2+ yrstreatment for 2+ yrs [B][B]
Augment AD with lithiumAugment AD with lithium [B] [B] If lithium augmentation effective, maintain If lithium augmentation effective, maintain
for 6/12+for 6/12+ [B] [B] If unable or unwilling to continue an If unable or unwilling to continue an
effective drug -> IPTeffective drug -> IPT [B] [B]
Crisis resolution and home treatment teamsCrisis resolution and home treatment teams [C] [C]
Atypical CasesAtypical Cases
Atypical depression in females: Atypical depression in females: MAOI’s if SSRIs failMAOI’s if SSRIs fail [B][B]
Psychotic depression: augment with Psychotic depression: augment with anti-psychoticanti-psychotic [C] [C]
Cognitive behaviour therapyCognitive behaviour therapy
for those who fail medical for those who fail medical treatmentstreatments
with history of relapse / limited with history of relapse / limited response to other measuresresponse to other measures
those at risk of relapse who do not those at risk of relapse who do not wish to continue drugswish to continue drugs
those with 2+ previous episodes of those with 2+ previous episodes of moderate or severe depressionmoderate or severe depression
Step 5: In-patient careStep 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 - 1Conclusion - 1We 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 - 2Conclusion - 2Drugs 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 effectiveBut ALL patients need to have hope, and an expectancy of improvement
Conclusion - 3Conclusion - 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
