NCT03874494

Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia

A Phase III, Multicenter, Randomized, Double-blind, Active-Controlled Study (Aripiprazole Tablets) to Evaluate the Efficacy and Safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 371 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia. A total of approximately 370 subjects will be included in the study, and randomized to Brexpiprazole (2\~4 mg/d) or Aripiprazole (10\~20 mg/d) in a 1:1 ratio.

Detailed description

Screening Phase: It will begin when informed consent form (ICF) is signed and be a maximum of 14 days, to evaluate the inclusion/exclusion criteria, collect information such as demographic data, medical history, wash out previous antipsychotic agents and other prohibited concomitant medications. Double-blind Treatment Phase: It lasts 6 weeks; the purpose is to compare the efficacy and safety of Brexpiprazole with Aripiprazole in the treatment of adults with acute schizophrenia. Follow-up Phase: All subjects will be followed up for safety reasons via telephone contact or clinic visit 30 (+ 2) days after the last dose of investigational medicinal product, collecting safety information (adverse events and concomitant medication).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole 2-4 mg/day
DRUG	Aripiprazole	Aripiprazole 10-20 mg/day

Timeline

• Start date: 2019-11-27
• Primary completion: 2021-08-06
• Completion: 2021-09-06
• First posted: 2019-03-14
• Last updated: 2025-04-18

Locations

1 site across 1 country: China