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Study details
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Cariprazine in Children with Bipolar Disorder

AbbVie
NCT IDNCT04777357ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

380

Study length

about 5.9 years

Ages

10–17

Locations

68 sites in AR, CA, FL +13

About this study

Researchers are testing cariprazine, a treatment, to see if it helps children (ages 10-17) with bipolar I disorder who are experiencing depressive episodes. The trial will last for about 2 years and involve around 380 participants. Participants will receive either cariprazine or a placebo, and their response to the treatment will be monitored through regular visits and assessments.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Cariprazine
  • 2.Take Placebo
PhasePhase 3
DrugCariprazine
Routeoral
Primary goalAbnormal Change from Baseline in Vital Signs

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low5%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

cariprazine

Drug routes

oral (Oral Capsule)

Endpoints

Primary: Abnormal Change from Baseline in Vital Signs, Change From Baseline in Abnormal Involuntary Movement Scale (AIMS), Change From Baseline in Barnes Akathisia Rating Scale (BARS), Change From Baseline in Simpson-Angus Scale (SAS), Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS), Number of Participants with Adverse Events

Body systems

Psychiatry / Mental Health