drugset
drugset / Trial / NCT04578756

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

NCT04578756 ↗

Phase 3 Completed 310 enrolled AbbVie
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-01
Primary completion
2025-10-06
Completion
2025-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cariprazine Small molecule — Oral

Indications

autism spectrum disorder bipolar I disorder schizophrenia