A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

Study type

Interventional

Primary purpose

Treatment

Allocation

Randomized

Intervention model

Parallel

Masking

Triple

Arms

2

Interventions

• Cariprazine Drug
• Placebo Drug

• Depression
• Bipolar I Disorder

Primary outcome

Number of Participants with Adverse Events (Baseline (Week 0) to Week 10); Abnormal Change from Baseline in Vital Signs (Baseline (Week 0) to Week 10); Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results (Baseline (Week 0) to Week 6); Change in Electrocardiogram (ECG) (Baseline (Week 0) to Week 6); Change From Baseline in Simpson-Angus Scale (SAS) (Baseline (Week 0) to Week 6); Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline (Week 0) to Week 10); Change From Baseline in Barnes Akathisia Rating Scale (BARS) (Baseline (Week 0) to Week 6); Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) (Baseline (Week 0) to Week 6); Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline (Week 0) to Week 6)

• Cariprazine

• NCT04777357 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.