Phase 3 N=46 Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Bipolar Disorder
Primary: YMRS — 10; 18.82; 4.29 score on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=28 Ziprasidone in Pediatric Bipolar Disorder
Bipolar Disorder
Primary: Young Mania Rating Scale (YMRS) — 12.70; 12.57 units on a scale
Phase 4 N=30 Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Bipolar Disorder · Mania
Primary: Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score — -14.5 Units on a scale
N/A N=7 Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Bipolar Disorder · Depression
Primary: K SADS-Present Version (KSADS-P) — 0; 2; 1; 0 participants
Phase 2 N=48 Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Bipolar Disorder
Primary: Young Mania Rating Scale (YMRS), — 19.61; 7.06; 5.68 units on a scale
Phase 3 N=350 Lurasidone Pediatric Bipolar Study
Bipolar I Depression
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…
Phase 4 N=51 Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
Bipolar Disorder · Mania
Primary: Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS) — -14.9 Units on a scale
Phase 4 N=61 Inositol and Omega-3 Fatty Acids in Pediatric Mania
Pediatric Bipolar Spectrum Disorders
Primary: Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS) — -4.8; -6.4; -10.2 units on a scale
Phase 3 N=296 Aripiprazole in Children and Adolescents With Bipolar I Disorder
Bipolar Disorder
Primary: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 — -14.04; -16.16; -8.67 points — p=<0.0001
Phase 3 N=298 Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Bipolar Disorder
Primary: Time From Randomization to the Occurrence of a Bipolar Event (TOBE) — 50; 155; 120; 163 Days — p=0.0717
Phase 3 N=65 Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Bipolar Disorder
Primary: Young Mania Rating Scale (YMRS) — 25.09; 30.59; 15.24; 10.22 units on a scale — p=<0.01
Phase 3 N=62 Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Bipolar Disorder
Primary: Young Mania Rating Scale (YMRS) — 24.8; 21.6 Scores on a scale
Phase 3 N=379 Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
Bipolar Disorder
Primary: Clinical Global Impressions-Bipolar Mania Improvement — 2.49; 2.73; 1.70 units on a scale
Phase 2 N=53 A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation
Mood Disorder · Mental Disorder Diagnosed in Childhood · Attention Deficit and Disruptive Behavior Disorder
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…
Phase 4 N=40 Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Bipolar Disorder
Primary: Mean Change in the Young Mania Rating Scale (YMRS) Score — -8.1 score on a scale
Phase 3 N=193 Pediatric Bipolar Depression
Bipolar Depression
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
Phase 2 N=34 Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation
Severe Mood Dysregulation
Primary: Clinical Global Impression-Severity-Severe Mood Dysregulation — 4.91; 3.62; 4.30; 4.42 units on a scale — p=.58
Phase 3 N=162 Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Bipolar Disorder
Primary: Young Mania Rating Scale (YMRS) Total Score Change From Baseline — -3.8; -4.0; -6.3; -6.1 score on scale
Phase 1 N=105 Lurasidone Pediatric Pharmacokinetics Study
Schizophrenia · Autism
Primary: Lurasidone Primary Pharmacokinetic Parameters — 78; 140; 300; 115 ng.h/mL
Phase 4 N=291 A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
Bipolar Depression
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
Phase 3 N=238 Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Bipolar Disorder
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
Phase 3 N=60 Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
Bipolar Disorder
Primary: Time in Weeks to Discontinuation — 25.93; 3.00 time in weeks to discontinuation
Phase 3 N=404 Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Bipolar Disorder, Pediatric
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
Phase 4 N=203 Study in Adolescents With Schizophrenia or Bipolar Disorder
Bipolar I Disorder · Schizophrenia
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
Phase 3 N=322 Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
Bipolar Disorder
Primary: Number of Participants Who Experienced Clinical or Laboratory Adverse Events — 197; 74 Participants
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…
N/A N=93 Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Borderline Personality Disorder · Emotional Problem
Primary: Maternal Emotion Dysregulation — 82.35; 91.8 score on a scale — p=.002
Phase 4 N=24 Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Substance Use Disorders · Bipolar Disorder · Mood Disorders
Primary: Change in Timeline Followback of Substance Use (TLFB) — 2.3; 3.3 Days
N/A N=76 PET and MRI Brain Imaging of Bipolar Disorder
Bipolar Disorder · Bipolar Depression · Unipolar Depression
Primary: Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS) — -44.49 Percent Change in HDRS-24 Score
N/A N=36 Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Bipolar Disorder
Primary: Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks — 21.5; 28.0 percent of medications not taken