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

Completed · Phase 3 · NCT04578756

Conditions: Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)

Research payments reported, 2025: $1.3M
U.S. investigators named: 34
Sites paid: 45
Planned or actual enrollment: 310

About the trial

Sponsor: AbbVie
Tested: Cariprazine Flexible Dose (drug), Cariprazine Flexible Dose (drug)
Dates: Started 2021-02-01; completion 2025-10-06
Results posted: Not yet

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.

From ClinicalTrials.gov, last updated 2025-10-27. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $1.3M in research payments for this study in 2025 (167 payments).

Products named: Vraylar

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.

At a glance

About the trial

Industry funding

U.S. investigators named on this study

Sites paid to run it