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
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
310actual
Sites
42
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-02-01 | actual | When the study began enrolling |
| Primary completion | 2025-10-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-06 | actual | The whole study's end, after follow-up |
| First posted | 2020-10-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Schizophrenia
- Bipolar I Disorder
- Autism Spectrum Disorder (ASD)
Interventions
- Drug: Cariprazine Flexible Dose
- Drug: Cariprazine Flexible Dose
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
measured Baseline Day 1 to Week 59
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
measured Baseline Day 1 to Week 52
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
measured Baseline Day 1 to Week 59
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
measured 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
measured Baseline Day 1 to Week 52
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
measured Baseline Day 1 to Week 52
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
measured Baseline Day 1 to Week 52
Change From Baseline in Simpson-Angus Scale (SAS)
measured Baseline Day 1 to Week 52
Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters
measured Baseline Day 1 to Week 52
Permalink · ABBV's whole pipeline · Catalyst calendar · Every registered study · What changed