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Andrew A. Nierenberg, MD Massachusetts General Hospital Harvard Medical School Lessons from STEP-BD for the Treatment of Bipolar Disorder.

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Presentation on theme: "Andrew A. Nierenberg, MD Massachusetts General Hospital Harvard Medical School Lessons from STEP-BD for the Treatment of Bipolar Disorder."— Presentation transcript:

1 Andrew A. Nierenberg, MD Massachusetts General Hospital Harvard Medical School Lessons from STEP-BD for the Treatment of Bipolar Disorder

2 STEP-BD Systematic Treatment Enhancement Program for Bipolar Disorder Evidence guided treatment Specialty bipolar clinics Integration of measurement and management Embedded randomized trials

3 Methods Mini International Neuropsychiatric Interview Affective Disorders Evaluation Form Clinical Monitoring form Self-administered waiting room form –www.manicdepressive.orgwww.manicdepressive.org Quarterly and yearly evaluations Participants followed for up to 2 years

4 Collaborative Care: Integration of Measurement and Management Shared measurement –Symptoms Depression Mania/hypomania Anxiety Irritability –Stress, alcohol, smoking, weight –Side effects –Functioning

5 Collaborative Care: Integration of Measurement and Management Shared measurement –Mood monitoring –Medication concordance Non-concordance open for discussion Negotiate –Goals –Medication changes Menu of reasonable choices Collaborative Care Workbook

6 STEP-BD Baseline Findings

7 Most Bipolar Patients report onset in childhood or adolescence Only 35% with onset > 18 About 65% with onset < 18 Almost a third with onset < 13 > to 18 < 13 Perlis RH for the STEP-BD group, Biol Psych 2004;55:

8 Age of Onset in Bipolar Disorder (STEP-1000) mean age of onset (SD 8.67) Perlis RH for the STEP-BD group, Biol Psych 2004

9 Childhood Onset With Greater Anxiety Comorbid Conditions Onset < 13 Onset 13 to 18 Onset > 18 Perlis RH for the STEP-BD group, Biol Psych 2004;55: N=983

10 Childhood and Adolescent Onset With Greater Comorbid Substance Abuse/Dependence and ADHD Onset < 13 Onset 13 to 18 Onset > 18 Perlis RH for the STEP-BD group, Biol Psych 2004;55: N=983

11 Depressive Polarity of First Episode: More lifetime depression Perlis et al., Biological Psychiatry 2005;58:549–553

12 Lifetime Anxiety Comorbidity in Bipolar Disorder – STEP 500 Agor=agoraphobia; GAD=generalized anxiety disorder; OCD=obsessive-compulsive disorder; PTSD=posttraumatic stress disorder; SAD=social anxiety disorder. Simon N, et al. Am J Psychiatry. 2004;161: * 51% 17% 9% 22% 10% 17% 18% AnyPanic ± Agor Agor Without Panic SADOCDPTSDGAD BP IBP II *P<0.001; P<0.005 * * * *

13 Anxiety Comorbidity Associated With Reduction in Longest Time Euthymic in Bipolar Disorder in Past 2 Years (N=469) Simon NM, et al. Am J Psychiatry. 2004;161: (n=233, 332) (n=236, 137) Current Anxiety Disorder Lifetime Anxiety Disorder (n=81, 37) (n 35, 17) (n=99, 55) (n=49, 26) (n=79, 22)(n=86, 56) Euthymic, d No Anxiety PD w/ AGOR SADPTSDAny Anxiety PD w/out AGOR OCD GAD * P<0.05; P<0.01; § P<0.001; * P< * * § § *

14 ADHD Comorbidity in Bipolar Adults ADHD Comorbid Shorter periods of wellness More likely –BPI –Symptomatic –> lifetime manic episodes –EtOH and drug abuse Less likely: –Recovered % N = 1000; Nierenberg et al., Biol Psychiatry 2005;57:1467–1473

15 Comorbid ADHD with more lifetime problems % N = 1000; Nierenberg et al., Biol Psychiatry 2005;57:1467–1473

16 Prevalence of ADHD with Mood Disorders % With% Without Other Comorbid*Comorbid ConditionsOdds Ratio MDD Dysthymia Bipolar Any Mood Disorder *eg, 21.2% of those with Bipolar Disorder during the previous 12 months have ADHD compared to 3.5% of those without MDD who have ADHD. Kessler RC, et al. Am J Psychiatry. 2006;163:

17 Prevalence of Mood Disorders with Adult ADHD % With % Without ADHD* ADHD MDD Dysthymia Bipolar Any Mood Disorder *eg, 19.4% of those with ADHD during the previous 12 months have Bipolar Disorder compared to 3.1% of those without ADHD who have Bipolar Disorder. Kessler RC, et al. Am J Psychiatry. 2006;163:

18 Most bipolar patients with lifetime comorbid substance use disorder recover from SUD 52% No SUD Weiss RD, Ostacher M, et.al. Recovery from Substance Use in Bipolar Disorder: Does it Matter J Clin Psychiatry. 2005; J Clin Psych. 2005; 66: Past SUD Current SUD 36% 12% 36% + 12% = 48% of bipolar patients have lifetime SUD. 36%/48% (3/4) of those with lifetime comorbid SUD recover from SUD 48% lifetime SUD

19 STEP-BD Results: Observational Prospective Findings

20 Higher bipolar relapse rate with residual symptoms Perlis et al., Am J Psychiatry Feb;163(2): Without residual symptoms With residual symptoms Without residual symptoms With residual symptoms

21 Less than 1/3 of symptomatic bipolar patients reach recovery and remain well over 2 years in STEP-BD Achieved recovery 58.5% –(< 2 mood symptoms for at least 8 weeks) Relapse into depression 34.7% Relapse into mood elevation 13.8% Total relapse rate 48.5% Total that stayed recovered over 2 years (100%-48.5%) 51.5% Total who recovered and remained free of depressive and mood elevation recurrences over 2 years (51.5% out of 58.5% who achieved remission) 30.1% Perlis et al., Am J Psychiatry Feb;163(2): N=1469 who entered symptomatic

22 Anxiety comorbid conditions with lower probability of recovery from bipolar depression in STEP-BD Otto et al., Br J Psychiatry 2006 Jul;189:20-5. N=248 Overall recovery rate = 80.7% Overall Hazard Ratio (HR)= (Chi sq=5.41, P=0.020) HR=0.452 for social anxiety disorder without anxiety with anxiety

23 Anxiety comorbid conditions with higher risk of relapse in bipolar disorder in STEP-BD Otto et al., Br J Psychiatry 2006 Jul;189:20-5. N=489 Overall relapse rate = 41.4% Overall Hazard Ratio (HR)= ( 2=10.9, P=0.001) HR=1.55 for one disorder HR=2.17 for two or more disorders HR=2.07 for social anxiety disorder HR=2.45 for PTSD without anxiety with anxiety

24 Embedded Randomized Trials

25 Sachs G et al. N Engl J Med 2007; /NEJMoa No Advantage or Disadvantage to Adding AD to Mood Stabilizers for Bipolar Depression

26 Adjunctive Psychosocial Interventions with Empirical Support for Adult Bipolar Disorder Cognitive-Behavioral Therapy (CBT) Family-Focused Therapy (FFT) Interpersonal and Social Rhythm Therapy (IPSRT) Collaborative Care Plus

27 Intensive psychosocial interventions for bipolar depression better than collaborative care Miklowitz et al., Arch Gen Psychiatry, in press 1-year recovery rate for intensive group, 105/163 [64.4%]; for CC, 67/130 [51.5%]; log-rank 2 (1) = 6.20, p = 0.013; hazard ratio (HR) = 1.47; 95% CI =

28 Treatment Resistant Bipolar Depression: Lamotrigine Added Might Help Nierenberg et al., Am J Psychiatry 2006;163;1-8

29 Valproate Associated Polycsytic Ovarian Syndrome (PCOS) PCOS –Menstrual cycle irregularities < or = 9 cycles per year –Hyperandrogenism Hirsuitism Acne Male pattern alopecia Elevated serum androgens –Obesity, insulin resistance, polycystic ovarian morphology

30 New Onset Oligoamenorrhea with Hyperandrogenism with Valproate % 2/449/86 Joffe et al. Valproate is associated with new-onset oligoamenorrhea with hyper- Androgenism in women with bipolar disorder. Biol Psych 2006;59: Median time to onset = 3 months with new onset PCOS

31 Questions that remain after STEP-BD What are the best acute and long-term treatments for bipolar depression? What are the best treatments to prevent mood episodes and restore functioning in generalizable populations?

32 Questions that remain after STEP-BD What are the best treatments for comorbid conditions (anxiety, substance abuse, ADHD)? –Substance use disorders are untreated What can decrease medical morbidity and overall mortality, including suicide?

33 Questions that remain after STEP-BD What biomarkers can be used to personalize acute and long-term treatment? –Molecular –Genetic –Imaging –Cognitive assessments –Other biomarkers

34 What are the best treatments of bipolar depression? Novel therapeutic interventions Do patients with BPII depression need mood stabilizers? After recovery from bipolar depression, what treatments promote long-term functioning and prevent relapse?

35 What are the best treatments for comorbid conditions and symptoms? Anxiety –Pharmacologic –Psychotherapeutic Substance abuse –Unique challenge of difficult to treat patients ADHD –Benefits and risks of psychostimulants Cognitive dysfunction Medical burdens

36 What is the best treatment for bipolar disorder with comorbid anxiety? Anxiety comorbidity –51% of STEP-BD cohort –associated with poorer outcomes No evidence-based treatment options –Antidepressants can exacerbate disease course –Benzodiazepines of concern due to high comorbid substance abuse rates in BP –No studies of psychotherapies for comorbid anxiety Novel psychosocial interventions needed

37 The sun and moon allude to the cyclical nature of bipolar disorder and the mission of the BTN: enduring commitment to clinical research on behalf of patients with bipolar disorder and their families. Designed by Gianna Marzilli Ericson


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