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.
← catalyst calendarNCT04777357 · readout ≤ 223 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
380estimated
Sites
81
Countries
Puerto Rico, Russia, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-04-28 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-03-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Depression
- Bipolar I Disorder
Interventions
- Drug: Cariprazine — also filed as Vraylar
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events
measured Baseline (Week 0) to Week 10
Abnormal Change from Baseline in Vital Signs
measured Baseline (Week 0) to Week 10
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results
measured Baseline (Week 0) to Week 6
Change in Electrocardiogram (ECG)
measured Baseline (Week 0) to Week 6
Change From Baseline in Simpson-Angus Scale (SAS)
measured Baseline (Week 0) to Week 6
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
measured Baseline (Week 0) to Week 10
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
measured Baseline (Week 0) to Week 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
measured Baseline (Week 0) to Week 6
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
measured Baseline (Week 0) to Week 6
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