trial

Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

NCTId NCT03238326
as of 2026-07-01
Add to landscapeMonitor thisAsk about this
at a glance
Phase 3 · Completed
Enrollment 295 (actual)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2025-04-22
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Completed
Enrollment
295 (actual)
Study type
Interventional
Allocation
Na
Model
Single Group
Masking
None
Start
2017-08-23
Primary completion
2025-04-22
Eligibility
ALL · 13 Years · 17 Years

Interventions & indications

Drugs
Brexpiprazole (Rexulti)

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
H. Lundbeck A/SCollaborator

Investigators

1
Heather Guthrie, MDStudy Director

Sites

57 total
Dothan, United StatesAnaheim, United StatesCulver City, United StatesLong Beach, United StatesAtlanta, United StatesKansas City, United StatesLake Charles, United StatesLas Vegas, United StatesNew York, United StatesRochester, United StatesKinston, United StatesCincinnati, United States

Linked catalysts

1
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance — primary completion2025-04-22

Facts & assertions

4 sourced
Enrollment
295
Phase
PHASE3
Primary Completion Date
2025-04-22
Status
COMPLETED
relationships
The graph out of here
drug
Brexpiprazole (Rexulti)
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
collaborator
H. Lundbeck A/S
company
indication
Schizophrenia
indication
Schizophrenia
indication
investigator
Heather Guthrie, MD
person