trial

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

NCTId NCT04578756
as of 2026-07-01
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at a glance
Phase 3 · Completed
Enrollment 310 (actual)
Sponsored by AbbVie
Primary completion 2025-10-06
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Completed
Enrollment
310 (actual)
Study type
Interventional
Allocation
Non Randomized
Model
Parallel
Masking
None
Start
2021-02-01
Primary completion
2025-10-06
Eligibility
ALL · 5 Years · 17 Years

Interventions & indications

Drugs
Cariprazine (Vraylar)

Sponsors

AbbVieLead Sponsor

Sites

42 total
Dothan, United StatesBentonville, United StatesAnaheim, United StatesLong Beach, United StatesOrange, United StatesOrange, United StatesRancho Cucamonga, United StatesSan Diego, United StatesUpland, United StatesDoral, United StatesGainesville, United StatesHialeah, United States

Linked catalysts

1
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerabilit — primary completion2025-10-06

Facts & assertions

4 sourced
Enrollment
310
Phase
PHASE3
Primary Completion Date
2025-10-06
Status
COMPLETED
relationships
The graph out of here
drug
Cariprazine (Vraylar)
drug
lead_sponsor
AbbVie
company
indication
Autism Spectrum Disorder (ASD)
indication
Bipolar I Disorder
indication
Schizophrenia
indication