Brexpiprazole in Patients With Acute Schizophrenia

Summary

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Timeline

Start

2013-03

Primary completion

2014-12

Completion

2014-12

Outcome

Missed primary endpoint

registry Placebo vs Brexpiprazole; p = 0.0560; Least square mean difference -4.1 (95% CI -8.2 to 0.1) NCT01810380 ↗

Publications

• Correll CU, Yildirim M, Zhang Z, Palma AM, Pham T, Pflug B. Efficacy and safety of brexpiprazole in early-episode schizophrenia: post hoc analysis of Phase 3 clinical trials in adults and adolescents. Psychiatry Res. 2026 Jun;360:117091. doi: 10.1016/j.psychres.2026.117091. Epub 2026 Mar 12.
• Ismail Z, Kapadia S, Palma AM, Yildirim M, Farovik A. Brexpiprazole for anxiety symptoms in schizophrenia: a pooled analysis of short- and long-term trials. Curr Med Res Opin. 2025 Aug;41(8):1535-1548. doi: 10.1080/03007995.2025.2552286. Epub 2025 Sep 11.
• Ismail Z, Meehan SR, Farovik A, Kapadia S, Palma AM, Zhang Z, McIntyre RS. Effects of brexpiprazole on patient life engagement in schizophrenia: post hoc analysis of Positive and Negative Syndrome Scale data. Curr Med Res Opin. 2025 Jan;41(1):145-153. doi: 10.1080/03007995.2024.2440059. Epub 2025 Jan 3.
• 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.

Drugs

Indications