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.

Summary

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Depression
• Bipolar I Disorder

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

10 to 17 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

AbbVie

Last updated on ClinicalTrials.gov

July 27, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites