drugset / Trial / NCT01668797
Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
Phase 3
Completed
524 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Quintiles, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
Timeline
- Start
- 2012-10
- Primary completion
- 2015-01
- Completion
- 2015-02
Outcome
Met primary endpoint
paper The final analysis showed that time to impending relapse was statistically significantly delayed with brexpiprazole treatment compared with placebo (P<.0001, log-rank test). PMID 27566723 ↗
paper The hazard ratio for the final analysis was 0.292 (95% confidence interval: 0.156, 0.548); PMID 27566723 ↗
Publications
- Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793.
- Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan.
- Correll CU, Shi L, Weiss C, Hobart M, Eramo A, Duffy RA, Weiller E, Baker RA. Successful switching of patients with acute schizophrenia from another antipsychotic to brexpiprazole: comparison of clinicians' choice of cross-titration schedules in a post hoc analysis of a randomized, double-blind, maintenance treatment study. CNS Spectr. 2019 Oct;24(5):507-517. doi: 10.1017/S1092852918001086.
- Fleischhacker WW, Hobart M, Ouyang J, Forbes A, Pfister S, McQuade RD, Carson WH, Sanchez R, Nyilas M, Weiller E. Efficacy and Safety of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):11-21. doi: 10.1093/ijnp/pyw076.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 1 mg | — |
| Subject | Brexpiprazole | Small molecule | 4 mg | — |