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

Study type

Interventional

Primary purpose

Treatment

Allocation

Non randomized

Intervention model

Parallel

Masking

None

Arms

11

Interventions

• Cariprazine Flexible Dose Drug

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

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period (Baseline Day 1 to Week 59); Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters (Baseline Day 1 to Week 52); Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters (Baseline Day 1 to Week 59); Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) (Baseline Day 1 to Week 52); Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale (Baseline Day 1 to Week 52); Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) (Baseline Day 1 to Week 52); Change From Baseline in Barnes Akathisia Rating Scale (BARS) (Baseline Day 1 to Week 52); Change From Baseline in Simpson-Angus Scale (SAS) (Baseline Day 1 to Week 52); Number of Participants With Clinically Significant Chan…

• Cariprazine

• NCT04578756 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.