Clinical Trial Search

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…

Primary: Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score — -12.6; -14.3; -6.8 units on a scale — p=<0.001

Primary: Change From Baseline In Young-Mania Rating Scale (YMRS) Score At Week 3 — -12.3; -10.7 units on a scale — p==0.1011

Primary: Change From Baseline In Young-Mania Rating Scale (YMRS) Score At Week 3 — -10.6; -10.8 units on a scale — p==0.8797

Primary: Young Mania Rating Scale (YMRS) — -11.3; -5.3 scores on a scale — p=<0.001

Primary: Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score — -14.0; -10.0 Change from Baseline in YMRS Total Score

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

Primary: Young Mania Rating Scale (YMRS) — -18.8 scores on a scale

Primary: Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores. — 4; 4; 4; 4 participants

Primary: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28) — -25.7; -26.1 score on a scale

Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -18.1; -12.4 score on a scale — p=<0.0001

Primary: Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) — 1.00; 1.00; 0.98; 0.98 Proportion of…

Primary: Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period — NA; NA; NA; NA days — p=0.5745

Primary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 — -12.5; -18.6; -18.5 score on a scale — p=<0.001

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

Primary: Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only — -3.0 units on a scale

Primary: Time to Intervention for a Mood Episode During Double Blind Period — 172.159; 143.133 Days — p=0.0104

Primary: Young Mania Rating Scale (YMRS) — -18.3 scores on a scale

Primary: The Montgomery-Asberg Depression Rating Scale (MADRS) — 31.95; 9.95; 10.95 score on a scale — p=<.001

Primary: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 — -14.04; -16.16; -8.67 points — p=<0.0001

Primary: Time to Intervention for Any Mood Episode (TIME) — NA; NA Days — p==0.438

Primary: The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups. — 11.4; 5.9 Scores on a scale

Primary: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) — 66.7 percentage of subjects

Primary: MADRS Score - Overall Change From Baseline — 13.7; 8.8 score on a scale — p=<.001

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

Primary: Timeline Follow Back (TLFB) — -0.82; -0.71 drinks per drinking day

Primary: Number of Participants With Response to Treatment" — 31; 28; 27 Participants

Primary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 — -15.3; -19.6 score on a scale — p=0.0004

Primary: Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase. — NA; 308 Days — p=< 0.0001

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