Clinical Trial Search

Primary: Change in the Scale for the Assessment of Negative Symptoms — -14; -25 Scores on a scale — p=.04

Primary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6. — 94.5; 94.0; 92.8; -18.6 units on a scale — p=0.0003

Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks — -26.6; -23.7; -27.0 units on a scale — p=0.05

Primary: Genetic Linkage — 5.2 log (odds ratio) — p=<0.001

Primary: Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score — -19.6; -16.5; -21.6 units on a scale

Primary: Change in Positive and Negative Syndrome Scale (PANSS) Total Score — -26.7; -28.6; -21.2 points — p=0.05

Primary: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants — 3.64; 2.83 kilograms per meter squared (kg/m^2) — p=0.150

Primary: Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score — -7.9 units on a scale

Primary: Number of Participants Demonstrating Improvement in Substance Use — 3; 3 participants

Primary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 — 89.6; 92.0; -19.3; -19.8 Units on a scale — p=0.935

Primary: Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse. — 19.39; 37.50 relapse rate(percentage of participants)…

Primary: Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. — -9.8; -17.3; -13.8; -7.9 units on a…

Primary: Lurasidone Primary Pharmacokinetic Parameters — 78; 140; 300; 115 ng.h/mL

Primary: Weight Gain and Other Side Effects

Primary: Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score — -14.5 Units on a scale

Primary: Change in DEXA % Body Fat — 1.81; 4.12; 1.66 percent body fat — p=<0.0001

Primary: Change in Weight — 0.70 lbs

Primary: Biomarkers — 287.37; 340.83; 492.33; 420.17 pg/mL

Primary: Loss of Effect Over Time — 7; 15; 6; 3 Participants

Primary: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score — -22.75; -23.95; -17.42 score on a scale — p=0.0136

Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 — -17.8; -23.7; -25.5 score on a scale — p=0.070

Primary: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time — 51.25; 55.13; 59.15; 60.08 score on a scale — p=0.0145

Primary: Positive and Negative Symptom Improvement — 41.3; 40.3; 36.6; 37.3 score on a scale

Primary: Pharmacokinetics: Cmax — 19.12; 23.22 ng/mL

Primary: Maximum Plasma Concentration (Cmax) of Asenapine — 1.84; 3.48; 9.24; 6.75 ng/mL

Primary: DEXA-measured Adiposity — 0.76; -0.43; -2.79 kilograms — p=0.01

Primary: Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline — 59.2…

Primary: Time to Relapse or an Impending Relapse — 0; 3; 1; 14 relapses

Primary: Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score — 0.00; 0.00; 1.40; 1.00 Scale of 0-6

Primary: Change in Weight (in Lbs.) — 24.9 lbs.