Treating Depression in Primary Care Strengths & Weaknesses of the NICE guideline

1. Treating Depression in Primary CareStrengths & Weaknesses of the NICE guideline David Goldberg Institute of Psychiatry King’s College, London

2. Evidence-based Medicine • How good is the evidence that, for the average person, medical treatment is better than a placebo?

3. 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?

4. 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

5. Patient-based Evidence What is the best treatment for me, with my particular characteristics and idiosyncrasies?

6. 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

7. Problems with RCTs of depression • In the USA, investigators often advertise for “patients” in newspapers, and pay for their co-operation

8. 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

9. 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?

10. 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 meta-analyses on positively selected studies?

11. Emperor’s New DrugsKirsch 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

12. Severity at baseline and response (-50%) after 4 weeks´ treatment: Angst placebo, moclobemide, imipramine

13. Irving Kirsch’s figure:

14. 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?

15. 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

16. 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 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

17. Will these two young women respond in the same way to treatment? Should the treatment be the same?

18. 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, self-harm and now - depression

19. 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

20. 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”

21. 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

22. “Stepped Care” Who needs treatment? Who should give it? When should patients be referred?

23. “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?

24. “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

25. Who is responsible for care? What do they do? Acute Wards Risk to Life Medication,ECT nursing care CMHT, OPD, crisis team, Day Hospital Treatment resistance frequent recurrences Medication, complex Psychological i.v’s PCMHW, GP, Counsellor, social worker, psychologist Moderate or Severe Depression Medication,Brief psych. interventions, support groups GP, Practice nurse, Practice counsellor Mild Depression Active Review: Self Help, Computerised CBT, Exercise Recognition Why do they do it?

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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]

33. 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!

34. Self-help vs. waiting listMead 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

35. 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

36. 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]

37. 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!

38. 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

39. Drug treatments in PCFirst 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]

40. Drug treatments in PCThe 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

41. Drug treatments in PCSecond 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

42. 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]

43. Enhanced careVonkorff & Goldberg BMJ 2001, 323, 948 Intensive follow up, by nurse, producing better outcomes at moderate cost

44. Enhanced careVonkorff & 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”

45. 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?

46. 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

47. 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

48. 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

49. 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

50. 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