1. The Challenges of Bipolar Disorders
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The Challenges of Bipolar Disorders
Can be difficult to diagnose
Often mistaken for unipolar depression
Many people have other comorbid disorders
A major health issue and a significant economic burden
1 of the top 5 causes of adult disability
Disagreement on treatment protocols for some forms of illness
1. Merikangas KR, et al. Arch Gen Psychiatry. 2007;64: Sachs GS, et al. Biol Psychiatry. 2003;53: WHO. The World Health Report Mental Health: New Understanding, New Hope.

2. Economic Burden of Bipolar Disorders
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Economic Burden of Bipolar Disorders
37B 40 30
$$ Billions 20 7B 10
Direct
Indirect
Type of Cost
1. Sachs GS, et al. Biol Psychiatry. 2003;53:
2. Revicki DA, et al. Pharmacoeconomics. 2005;23:

3. The STEP-BD Initiative Sought Answers to These Questions
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The STEP-BD Initiative Sought Answers to These Questions
What are the best treatments for depressive states?
Is psychotherapy a valuable adjunct?
What is the longitudinal outcome with algorithm-guided therapy?
Are there any predictors of outcome?
How can we prevent relapse and maintain durable remission?
STEP-BD = Systematic Treatment Enhancement Program for Bipolar Disorder.
Sachs GS, et al. Biol Psychiatry. 2003;53:

4. The Bipolar Spectrum Bipolar I Bipolar II Cyclothymic Disorder
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The Bipolar Spectrum
Bipolar I
Bipolar II
Cyclothymic Disorder
Bipolar NOS

5. Overview of the STEP-BD Study
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Overview of the STEP-BD Study
>4000 people enrolled 1999–2005
16 clinical sites participated throughout the entire study
Full spectrum of bipolar disorders
All participants on a mood stabilizer
Goal: ≤2 symptoms for at least 8 weeks
Sachs GS, et al. Biol Psychiatry. 2003;53:

6. Patient had same treating psychiatrist throughout entire study
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Platform for STEP-BD
Patient had same treating psychiatrist throughout entire study
Standardized Pathway of Care (SPC)
Randomized Trials Pathway (RTP)
If patient has relevant symptoms and consents, can become part of a trial
SPC Menu of “Reasonable Choices”
First-line treatments for
Acute depression
Refractory depression
Acute mania
Refractory mania
Rapid cycling
Relapse prevention
Pregnancy
Substance abuse
Other comorbidity
Acute MDD
Anyone in SPC or RTP can opt in to trials
Relapse prevention
Psycho- therapy options
Refract MDD
Acute mania
MDD = major depressive disorder.
Sachs GS, et al. Biol Psychiatry. 2003;53:

7. Psychotherapy Trial in STEP-BD
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Psychotherapy Trial in STEP-BD
Randomized Trial: Relapse Prevention
CBT can correct distorted thoughts
Collaborative care = the study control
IPSRT can help sleep/ wake patterns and social behavior
FFT can strengthen the family support system
CBT
IPSRT
FFT
Collab care
Anyone in the Standardized Care Pathway or a randomized trial could opt to add a form of intense psycho-therapy to their treatment
All 3 forms of psychotherapy helped more than collaborative care
CBT = cognitive behavioral therapy; IPSRT = interpersonal and social rhythm therapy; FFT = family-focused therapy.
Miklowitz, DJ, et al. Curr Psychiatric Rep. 2006;8:

8. Patient had same treating psychiatrist throughout entire study
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Example of Opting In to a Randomized Trial of Medications or Psychotherapy
Patient had same treating psychiatrist throughout entire study
Standardized Pathway of Care
Randomized Trial Pathway
Nonresponsive acute depression
Risperidone
Can stay in SPC
Refract MDD
Lamotrigine
Psychother-apy options
Inositol
Can opt in any time
Sachs GS, et al. Biol Psychiatry. 2003;53:

9. Antidepressants as Adjuncts to Mood Stabilizers in MDD
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Antidepressants as Adjuncts to Mood Stabilizers in MDD
Patients had to agree to take an approved mood stabilizer or atypical antipsychotic
Bupropion or paroxetine vs placebo
Double-blinded, randomized; 24 weeks
No additional benefit seen from adding either antidepressant or placebo
No increase in risk of treatment-emergent affective switches
Sachs GS, et al. N Engl J Med. 2007;356:

10. Outcomes Predictors Variables Indicative of Worse Outcomes
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Outcomes Predictors Variables Indicative of Worse Outcomes
Length of time spent in depressive state
The number of residual symptoms continuing after treatment
Anxiety disorders and eating disorders = increased risk of depressive recurrence
Substance abuse = increased risk of manic recurrence
Perlis RH, et al. Arch Gen Psychiatry. 2007;64: