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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=505 Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Bipolar Depression
Primary: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) — -10.7; -15.4; -15.4 units on a scale — p=<0.001
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 3 N=525 A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Bipolar Depression
Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 — -10.6; -13.6; -12.6 units on a scale — p=0.007
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=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 4 N=92 Acute Psychotherapy for Bipolar II Depression
Bipolar Disorder · Depression
Primary: Remission — 16; 13 Participants — p=<0.0001
Phase 3 N=298 Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
Bipolar Disorder · Depression, Bipolar
Primary: Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -14.7; -13.2 scores on scale — p=0.7921
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 4 N=86 Maintenance Treatment of Bipolar Depression
Bipolar Disorder · Depression
Primary: Mania Rating Scale — 4.54; 5.57 units on a scale
Phase 3 N=348 Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
Bipolar Depression
Primary: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) — -17.1; -13.5 units on a scale — p=0.005
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 3 N=356 Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Bipolar Depression
Primary: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) — -11.8; -10.4 units on a scale — p=0.176
Phase 3 N=377 Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Bipolar Depression
Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -16.70; -12.12 score on a scale — p=<0.0001
N/A N=10 iTBS in Bipolar I Depression
Bipolar Depression · Bipolar I Disorder
Primary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score — 16.9 score 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 3 N=817 Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Bipolar Depression
Primary: Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment — 529 participants
Phase 2 N=50 Scopolamine in Bipolar Depression
Bipolar Disorder Depression
Primary: Hamilton Depression Rating Scale Score After Last Treatment — 12.0; 13.0 units on a scale — p=0.3
Phase 3 N=488 Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
Bipolar Disorder · Depression
Primary: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6 — -12.6; -15.1; -15.6 score on a scale — p=0.0331
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 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=7 Tranylcypromine Treatment of Bipolar Depression
Bipolar Disorder I or II
Primary: 29 Item Hamilton Rating Scale for Depression (HamD29) — 27.0; 5.8 Hamilton Depression score
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 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 4 N=32 12- Week Open Label Treatment of Refractory Bipolar Depression
Bipolar Disorder
Primary: Primary Measure:Reduction in Depression Symptoms — 16 participants
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 3 N=488 Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Bipolar Depression · Major Depressive Disorder
Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -18.1; -12.4 score on a scale — p=<0.0001
Phase 3 N=119 Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
Bipolar Disorder · Bipolar Depression
Primary: MADRS Rating Scale Change — 13.1; 15.2 units on a scale — p=0.17
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=26 Intensive TMS for Bipolar Depression
Bipolar Depression · Treatment Resistant Depression
Primary: Clinical Efficacy of High Dose Spaced Theta Burst (HDS-TBS) — 30.4; 28; 10.5; 25.3 score on a scale — p=<0.001