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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.
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Job 1845.02--Slideset#1 Thase 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 The Challenges of Bipolar Disorders 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.
Job 1845.02--Slideset#1 Thase Economic Burden of Bipolar Disorders 37B 40 30 $$ Billions 20 7B 10 0 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.
Job 1845.02--Slideset#1 Thase 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;53:1028-1042.
Job 1845.02--Slideset#1 Thase Bipolar I Bipolar II Cyclothymic Disorder Bipolar NOS The Bipolar Spectrum
Job 1845.02--Slideset#1 Thase 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;53:1028-1042.
Job 1845.02--Slideset#1 Thase Standardized Pathway of Care (SPC) Randomized Trials Pathway (RTP) Acute MDD Relapse prevention Psycho- therapy options Anyone in SPC or RTP can opt in to trials Refract MDD If patient has relevant symptoms and consents, can become part of a trial Platform for STEP-BD Patient had same treating psychiatrist throughout entire study 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 mania MDD = major depressive disorder. Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042.
Job 1845.02--Slideset#1 Thase CBT can correct distorted thoughts Anyone in the Standardized Care Pathway or a randomized trial could opt to add a form of intense psycho-therapy to their treatment CBT IPSRT FFT IPSRT can help sleep/ wake patterns and social behavior FFT can strengthen the family support system Collaborative care = the study control Collabcare Psychotherapy Trial in STEP-BD Randomized Trial: Relapse Prevention 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.
Job 1845.02--Slideset#1 Thase Randomized Trial Pathway Standardized Pathway of Care RefractMDD Risperidone Lamotrigine Inositol Example of Opting In to a Randomized Trial of Medications or Psychotherapy Patient had same treating psychiatrist throughout entire study Nonresponsive acute depression Can stay in SPC Psychother-apy options Can opt in any time SachsGS, et al. Biol Psychiatry. 2003;53:1028-1042.
Job 1845.02--Slideset#1 Thase 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;356:1711-1722.
Job 1845.02--Slideset#1 Thase Outcomes PredictorsVariables 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;64:419-427.