drugset

drugset / Trial / NCT03238326

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

NCT03238326 ↗

Phase 3 Completed 295 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc. H. Lundbeck A/S · collab

NaSingle-groupOpen-labelSupportive care

Summary

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Timeline

Start: 2017-08-23
Primary completion: 2025-04-22
Completion: 2025-04-22

Publications

Atkinson SD, Shah A, Burgess MV, Hefting N, Chen D, Ward C. Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia: A Long-Term, Open-Label Study. JAACAP Open. 2024 May 27;3(2):313-322. doi: 10.1016/j.jaacop.2024.04.005. eCollection 2025 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	1 mg	Oral
Subject	Brexpiprazole	Small molecule	4 mg	Oral

Indications