STEP-BD. Methods. STEP-BD Baseline Findings. Lessons from STEP-BD for the Treatment of Bipolar Disorder
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1 Lessons from for the Treatment of Bipolar Disorder Andrew A. Nierenberg, MD Massachusetts General Hospital Harvard Medical School Systematic Treatment Enhancement Program for Bipolar Disorder Evidence guided treatment Specialty bipolar clinics Integration of measurement and management Embedded randomized trials Methods Mini International Neuropsychiatric Interview Affective Disorders Evaluation Form Clinical Monitoring form Self-administered waiting room form Quarterly and yearly evaluations Participants followed for up to years Collaborative Care: Integration of Measurement and Management Shared measurement Symptoms Depression Mania/hypomania Anxiety Irritability Stress, alcohol, smoking, weight Side effects Functioning 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 Baseline Findings 1
2 Most Bipolar Patients report onset in childhood or adolescence Age of Onset in Bipolar Disorder (STEP-1) 8% 7% mean age of onset (SD 8.67) 3% > 18 < to 18 8% Only 3% with onset > 18 About 6% with onset < 18 Almost a third with onset < 13 6% % 4% 3% % 1% 37% % Perlis RH for the group, Biol Psych 4;: Age of Onset Perlis RH for the group, Biol Psych Childhood Onset With Greater Anxiety Comorbid Conditions Any Anxiety Onset < 13 Onset 13 to 18 Panic w Agor Onset > 18 Agor w/o Panic Social Phobia N=983 GAD PTSD Childhood and Adolescent Onset With Greater Comorbid Substance Abuse/Dependence and ADHD Onset < 13 Onset 13 to 18 Onset > 18 N=983 Any Anxiety Alcohol Substance ADHD Perlis RH for the group, Biol Psych 4;: Perlis RH for the group, Biol Psych 4;: Depressive Polarity of First Episode: More lifetime depression Lifetime Anxiety Comorbidity in Bipolar Disorder STEP 6 1% 17% 9% % 1% 17% 18% BP I BP II Any Panic ± Agor Agor Without Panic SAD OCD PTSD GAD P<.1; P<. Perlis et al., Biological Psychiatry ;8:49 3 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. 4;161:-9.
3 Euthymic, d Anxiety Comorbidity Associated With Reduction in Longest Time Euthymic in Bipolar Disorder in Past Years (N=469) No Anxiety (n=33, 33) Any Anxiety (n=36, 137) PD w/ AGOR (n=81, 37) Current Anxiety Disorder Lifetime Anxiety Disorder PD w/out AGOR (n 3, 17) P<.; P<.1; P<.1; P<.1 SAD (n=99, ) OCD (n=49, 6) PTSD (n=79, ) GAD (n=86, 6) % ADHD Comorbidity in Bipolar Adults 9. Lifetime ADHD.9 Current ADHD ADHD Comorbid Shorter periods of wellness More likely BPI Symptomatic > lifetime manic episodes EtOH and drug abuse Less likely: Recovered Simon NM, et al. Am J Psychiatry. 4;161:-9. N = 1; Nierenberg et al., Biol Psychiatry ;7: % 1 1 Comorbid ADHD with more lifetime problems > Manic Episodes Lifetime suicide attempts Lifetime violence Lifetime legal problems N = 1; Nierenberg et al., Biol Psychiatry ;7: ADHD No ADHD Prevalence of ADHD with Mood Disorders % With % Without Other Comorbid Comorbid Conditions Odds Ratio MDD Dysthymia Bipolar Any Mood Disorder eg, 1.% of those with Bipolar Disorder during the previous 1 months have ADHD compared to 3.% of those without MDD who have ADHD. Kessler RC, et al. Am J Psychiatry. 6;163: 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 1 months have Bipolar Disorder compared to 3.1% of those without ADHD who have Bipolar Disorder. Kessler RC, et al. Am J Psychiatry. 6;163: Most bipolar patients with lifetime comorbid substance use disorder recover from SUD 36% + 1% = 48% of bipolar patients have lifetime SUD. 36%/48% (3/4) of those with lifetime comorbid SUD recover from SUD % No SUD Weiss RD, Ostacher M, et.al. Recovery from Substance Use in Bipolar Disorder: Does it Matter J Clin Psychiatry. ; J Clin Psych. ; 66: % Past SUD 1% Current SUD 48% lifetime SUD 3
4 Higher bipolar relapse rate with residual symptoms Results: Observational Prospective Findings Without residual symptoms Without residual symptoms With residual symptoms With residual symptoms Perlis et al., Am J Psychiatry. 6 Feb;163():17-4. Less than 1/3 of symptomatic bipolar patients reach recovery and remain well over years in Achieved recovery 8.% (< mood symptoms for at least 8 weeks) Relapse into depression 34.7% Relapse into mood elevation 13.8% Total relapse rate 48.% Total that stayed recovered over years (1%-48.%) 1.% Total who recovered and remained free of depressive and mood elevation recurrences over years (1.% out of 8.% who achieved remission) 3.1% N=1469 who entered symptomatic Perlis et al., Am J Psychiatry. 6 Feb;163():17-4. Anxiety comorbid conditions with lower probability of recovery from bipolar depression in without anxiety with anxiety Otto et al., Br J Psychiatry 6 Jul;189:-. N=48 Overall recovery rate = 8.7% Overall Hazard Ratio (HR)=.661 (Chi sq=.41, P=.) HR=.4 for social anxiety disorder Anxiety comorbid conditions with higher risk of relapse in bipolar disorder in with anxiety without anxiety N=489 Overall relapse rate = 41.4% Overall Hazard Ratio (HR)= ( =1.9, P=.1) HR=1. for one disorder HR=.17 for two or more disorders HR=.7 for social anxiety disorder HR=.4 for PTSD Embedded Randomized Trials Otto et al., Br J Psychiatry 6 Jul;189:-. 4
5 No Advantage or Disadvantage to Adding AD to Mood Stabilizers for Bipolar Depression 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 Sachs G et al. N Engl J Med 7;1.16/NEJMoa6413 Intensive psychosocial interventions for bipolar depression better than collaborative care Treatment Resistant Bipolar Depression: Lamotrigine Added Might Help 8 7 Intensive Treatment Collaborative Care 6 % Well Month 1-year recovery rate for intensive group, 1/163 [64.4%]; for CC, 67/13 [1.%]; log-rank χ (1) = 6., p =.13; hazard ratio (HR) = 1.47; 9% CI = Miklowitz et al., Arch Gen Psychiatry, in press Nierenberg et al., Am J Psychiatry 6;163;1-8 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 % New Onset Oligoamenorrhea with Hyperandrogenism with Valproate with new onset PCOS 1.4 No Valproate 1. Valproate /44 9/86 Median time to onset = 3 months Joffe et al. Valproate is associated with new-onset oligoamenorrhea with hyper- Androgenism in women with bipolar disorder. Biol Psych 6;9:
6 Questions that remain after 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? Questions that remain after 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? Questions that remain after What biomarkers can be used to personalize acute and long-term treatment? Molecular Genetic Imaging Cognitive assessments Other biomarkers 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? 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 What is the best treatment for bipolar disorder with comorbid anxiety? Anxiety comorbidity 1% of 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 6
7 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 7
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