Phase 4 N=129 Antidepressant Therapy in Treating Bipolar Type II Major Depression
Bipolar Disorder · Depression
Primary: Depressive Relapse — 3; 4 Participants
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Phase 3 N=25 Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
Bipolar II Disorder
Primary: Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10 — 4; 3; 10; 8 participants
Phase 4 N=92 Acute Psychotherapy for Bipolar II Depression
Bipolar Disorder · Depression
Primary: Remission — 16; 13 Participants — p=<0.0001
Phase 4 N=150 Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
Depression · Bipolar Disorder · Bipolar Depression
Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores — -15.7; -13.8; -16.0; -15.5 score on a scale — p=.59
N/A N=20 Bipolar Intervention Study: Cognitive Interpersonal Therapy
Mania · Hypomania · Bipolar Affective Disorder
Primary: Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) — 26.20; 20.20; 16.11; 15.22 units on a scale — p=0.05
Phase 4 N=86 Maintenance Treatment of Bipolar Depression
Bipolar Disorder · Depression
Primary: Mania Rating Scale — 4.54; 5.57 units on a scale
Phase 4 N=30 Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Bipolar II Disorder · Major Depressive Episode
Primary: The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores — 23.1; 10.57 Scores on a scale — p=<0.0001
Phase 4 N=55 Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II
Bipolar II Disorder
Primary: Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity — 37; 21 percentage of participants
N/A N=16 A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder
Bi-polar II Disorder
Primary: Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2 — -13.01; -3.76 units on a scale — p=0.016
Phase 3 N=54 Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Bipolar Disorder
Primary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -9.64; -5.32 units on a scale
Phase 3 N=57 Lamotrigine for Symptoms of Geriatric Bipolar Depression
Bipolar Disorder · Depression, Bipolar
Primary: Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) — -15.5 units on a scale — p=<.01
Phase 4 N=41 Iloperidone in Mixed States of Bipolar Disorder
Bipolar Disorder
Primary: Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores — 35.7; 61.8; 25; 48 percentage change in score on BISS scale…
Phase 4 N=21 Brexpiprazole for Bipolar Depression
Bipolar Depression
Primary: The Montgomery-Asberg Depression Rating Scale (MADRS) — 31.95; 9.95; 10.95 score on a scale — p=<.001
N/A N=29 Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Bipolar Disorder · Anxiety Disorders
Primary: Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale — 14; 18.81; 11.78; 17.70 Units on scale — p=.02
Phase 4 N=189 Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
Bipolar Disorder · Major Depression
Primary: HAM-D 17 Item: Hamilton Depression Rating Scale — 6.6; 4.91; 2.333; 3.75 score on a scale
Phase 3 N=420 Lamotrigine Phase III Study in Bipolar I Disorder
Bipolar Disorder
Primary: Time to Intervention for Any Mood Episode (TIME) — NA; NA Days — p==0.438
N/A N=13 Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder
Bipolar Disorder
Primary: Brain Activity (Beta Power) in Left vLPFC — -88.78; 1437.64; 13.43; -128.00 Percentage of change post versus pre — p=0.29389090
Phase 3 N=62 Bipolar Depression Before and After Lamotrigine Treatment
Bipolar Depression
Primary: Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group — 27.79…
Phase 2 N=35 A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
Bipolar Disorder I · Bipolar Disorder II · Major Depressive Episode
Primary: Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) — 16 Participants
Phase 4 N=177 Prevention of Relapse & Recurrence of Bipolar Depression
Bipolar Disorder
Primary: Number of Participants With Relapse of Major Depressive Episode Within 1 Year — 4; 5 Participants
N/A N=7 Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Bipolar Disorder · Depression
Primary: K SADS-Present Version (KSADS-P) — 0; 2; 1; 0 participants
Phase 4 N=34 Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Metabolic Syndrome · Bipolar Depression · Insulin Resistance
Primary: Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score — -16.5 units on a scale
Phase 3 N=554 Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Bipolar Depression
Primary: Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -18.9; -20.7; -19.7 score on a scale — p=0.514
Phase 4 N=40 Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging
Bipolar Disorder
Primary: Montgomery-Asberg Depression Rating Scale — -39.24 Percent change in MADRS from baseline
Phase 4 N=202 A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Bipolar I Disorder
Primary: Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint. — -10.15; -7.68 units on a scale — p=<0.001
N/A N=44 Transcranial Direct Current Stimulation Therapy for Bipolar Depression
Depression, Bipolar · Bipolar Disorder · Mood Disorders
Primary: Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ] — 34 Participants
Phase 2 N=341 A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
Depressive Episode · Bipolar 1 Depression
Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 — -19.485; -19.324; -16.196 units on a scale — p=0.044
Phase 3 N=528 Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Bipolar Depression
Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -16.2; -16.9; -14.5 score on a scale — p=0.021
Phase 3 N=514 Olanzapine Treatment of Patients With Bipolar I Disorder
Depression, Bipolar
Primary: Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) — 29.36; 28.69; -14.26; -11.71 units on a scale — p=0.018
Phase 3 N=431 A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Bipolar Disorder
Primary: Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -10.1; -14.4; -12.6 units on a scale — p=0.034