Clinical Trial Search

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 Young-Mania Rating Scale (YMRS) Score At Week 3 — -10.6; -10.8 units on a scale — p==0.8797

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 in the Young Mania Rating Scale (YMRS) Total Score at the End of the 3-week Treatment Period, in Relation to the Baseline. — -14.2; -12.5; -10.3 units on a scale

Primary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 — -8.91; -15.02 score on a scale — p=<0.0001

Primary: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) — -22.8; -20.1 Scores on a scale

Primary: Symptoms of Mania, as Measured by Young Mania Rating Scale — 5.7; 11.1; 10.0 units on a scale

Primary: Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) — -10.19; -10.95; -9.47 scores on scale — p=0.1077

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: 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: Mean Change in CGI-BP-OS After 1 Week of Treatment — -1.4; .8 units on a scale — p=.08

Primary: Remission — 16; 13 Participants — p=<0.0001

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: Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 — 1.00; 1.00; 0.95; 0.96 proportion of participants — p=0.014

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

Primary: Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) — -11.54; -13.57 Units on a scale — p=0.058

Primary: Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7 — 14.8; 13.9 units on a scale

Primary: Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS) — -14.9 Units on a scale

Primary: Sedation Score — 0.5; 0.5; 0.6; 0.6 units on a scale

Primary: Young Mania Rating Scale (YMRS) — 5.5; 11.8; 7.5; 3 score on a scale

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: Young Mania Rating Scale (YMRS) — -12.3; -9.6 units on a scale — p=.45

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

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: Brain Activity (Beta Power) in Left vLPFC — -88.78; 1437.64; 13.43; -128.00 Percentage of change post versus pre — p=0.29389090

Primary: Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21 — -14.4; -14.9; -10.9 Score on a scale — p=0.0136

Primary: Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo — -4.9; -8.1; -9.0 units on a scale — p=<0.0001

Primary: Time in Weeks to Discontinuation — 25.93; 3.00 time in weeks to discontinuation