Transcript Sample Presentation Title Slide

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Job 1845.02--Slideset#1 Thase
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The Challenges of Bipolar Disorders
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Can be difficult to diagnose
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Often mistaken for unipolar depression
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Many people have other comorbid disorders
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A major health issue and a significant
economic burden
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1 of the top 5 causes of adult disability
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Disagreement on treatment protocols for
some forms of illness
1. Merikangas KR, et al. Arch Gen Psychiatry. 2007;64:543-552.
2. Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042.
3. WHO. The World Health Report 2001. Mental Health: New Understanding, New Hope.
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Economic Burden of Bipolar Disorders
37B
$$ Billions
40
30
20
10
0
7B
Direct
Indirect
Type of Cost
1. Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042.
2. Revicki DA, et al. Pharmacoeconomics. 2005;23:583-594.
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The STEP-BD Initiative Sought
Answers to These Questions
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What are the best treatments for depressive
states?
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Is psychotherapy a valuable adjunct?
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What is the longitudinal outcome with
algorithm-guided therapy?
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Are there any predictors of outcome?
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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;53:1028-1042.
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The Bipolar Spectrum
Bipolar I
Bipolar II
Cyclothymic Disorder
Bipolar NOS
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Overview of the STEP-BD Study
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>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;53:1028-1042.
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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
MDD = major depressive disorder.
Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042.
Acute
MDD
Refract
MDD
Acute
mania
Relapse
prevention
Psychotherapy
options
Anyone in
SPC or RTP
can opt in
to trials
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Psychotherapy Trial in STEP-BD
Randomized Trial:
Relapse Prevention
Anyone in the
Standardized
Care Pathway or
a randomized
trial could opt
to add a form of
intense psychotherapy to their
treatment
CBT can correct
distorted thoughts
CBT
IPSRT
IPSRT can help sleep/
wake patterns and
social behavior
FFT
Collab
care
FFT can strengthen the
family support system
Collaborative care =
the study control
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;8:498-503.
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Example of Opting In to a Randomized
Trial of Medications or Psychotherapy
Patient had same treating psychiatrist throughout entire study
Randomized
Trial Pathway
Standardized
Pathway of Care
Nonresponsive acute depression
Risperidone
Can stay in SPC
Refract
MDD
Psychotherapy options
Lamotrigine
Inositol
Can opt in
any time
Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042.
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Antidepressants as Adjuncts to Mood
Stabilizers in MDD
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Patients had to agree to take an approved
mood stabilizer or atypical antipsychotic
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Bupropion or paroxetine vs placebo
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Double-blinded, randomized; 24 weeks
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No additional benefit seen from adding
either antidepressant or placebo
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No increase in risk of treatment-emergent
affective switches
Sachs GS, et al. N Engl J Med. 2007;356:1711-1722.
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Outcomes Predictors
Variables Indicative of Worse Outcomes
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Length of time spent in depressive state
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The number of residual symptoms
continuing after treatment
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Anxiety disorders and eating disorders
= increased risk of depressive recurrence
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Substance abuse = increased risk of manic
recurrence
Perlis RH, et al. Arch Gen Psychiatry. 2007;64:419-427.
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