The Challenges of Bipolar Disorders

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The Challenges of Bipolar Disorders 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 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;64:543-552. 2. Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042. 3. WHO. The World Health Report 2001. Mental Health: New Understanding, New Hope.

Economic Burden of Bipolar Disorders PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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;53:1028-1042. 2. Revicki DA, et al. Pharmacoeconomics. 2005;23:583-594.

The STEP-BD Initiative Sought Answers to These Questions PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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.

The Bipolar Spectrum Bipolar I Bipolar II Cyclothymic Disorder PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM The Bipolar Spectrum Bipolar I Bipolar II Cyclothymic Disorder Bipolar NOS

Overview of the STEP-BD Study PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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.

Patient had same treating psychiatrist throughout entire study PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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;53:1028-1042.

Psychotherapy Trial in STEP-BD PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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;8:498-503.

Patient had same treating psychiatrist throughout entire study 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 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;53:1028-1042.

Antidepressants as Adjuncts to Mood Stabilizers in MDD PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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.

Outcomes Predictors Variables Indicative of Worse Outcomes PIKSlideTemplateBB7-9.ppt1526-Regenstein#2SMv1.2-9.ppt 4/4/2019 3:39 PM Job 1845.02--Slideset#1 Thase 4/4/2019 3:39:21 PM 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;64:419-427.