Clinical Trial Search

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: Young Mania Rating Scale (YMRS) — 12.70; 12.57 units on a scale

Primary: Time From Randomization to the Occurrence of a Bipolar Event (TOBE) — 50; 155; 120; 163 Days — p=0.0717

Primary: Young Mania Rating Scale (YMRS), — 19.61; 7.06; 5.68 units on a scale

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: YMRS — 10; 18.82; 4.29 score on a scale

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

Primary: Young Mania Rating Scale (YMRS) — 25.09; 30.59; 15.24; 10.22 units on a scale — p=<0.01

Primary: Clinical Global Impressions-Bipolar Mania Improvement — 2.49; 2.73; 1.70 units on a scale

Primary: Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS) — -4.8; -6.4; -10.2 units on a scale

Primary: Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) — -29.6; -27.3 Scores on a scale

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

Primary: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 — -28.43; -23.40 units on a scale — p=0.003

Primary: K SADS-Present Version (KSADS-P) — 0; 2; 1; 0 participants

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: Young Mania Rating Scale (YMRS) — 24.8; 21.6 Scores on a scale

Primary: Percentage of Participants That "Much Improved" (Score of 2) in, or "Completely Recovered" (Score of 1) From Their Irritability Severity, as Measured With the Clinical…

Primary: Clinical Global Impression-Severity-Severe Mood Dysregulation — 4.91; 3.62; 4.30; 4.42 units on a scale — p=.58

Primary: Mean Change in the Young Mania Rating Scale (YMRS) Score — -8.1 score on a scale

Primary: Change From Baseline in Y-MRS Total Score at Day 21 — -9.6; -12.3; -15.1; -15.9 score on a scale — p=0.008

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: Young Mania Rating Scale (YMRS) Total Score Change From Baseline — -3.8; -4.0; -6.3; -6.1 score on scale

Primary: Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4 — 26.2; 27.0; -13.8; -9.9 units on a scale — p=0.0005

Primary: Number of Participants Who Experienced Clinical or Laboratory Adverse Events — 197; 74 Participants

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

Primary: Change in Affective Reactivity Index - Youth (ARI-Y) — -2.9; -0.8 score on a scale

Primary: Time to Remission — 13.67; 11.33 weeks

Primary: Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy…

Primary: Change in Total Score on the BDD-Y-BOCS Scale — -12.27; -9.53 units on a scale