Trials / Completed
CompletedNCT04578756
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cariprazine Flexible Dose | 1 capsule to be taken orally at approximately the same time of day (morning or evening) |
| DRUG | Cariprazine Flexible Dose | Dose solution (in milliliters) to be taken orally at approximately the same time of day (morning or evening) |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2025-10-06
- Completion
- 2025-10-06
- First posted
- 2020-10-08
- Last updated
- 2025-10-27
Locations
42 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04578756. Inclusion in this directory is not an endorsement.