# 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** · PHASE3 · COMPLETED · sponsor: **AbbVie** · enrollment: 310 (actual)

## Conditions studied

- Schizophrenia
- Bipolar I Disorder
- Autism Spectrum Disorder (ASD)

## Interventions

- **DRUG:** Cariprazine Flexible Dose
- **DRUG:** Cariprazine Flexible Dose

## Key facts

- **NCT ID:** NCT04578756
- **Lead sponsor:** AbbVie
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-02-01
- **Primary completion:** 2025-10-06
- **Final completion:** 2025-10-06
- **Target enrollment:** 310 (ACTUAL)
- **Last updated:** 2025-10-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04578756

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04578756. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*