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Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia

NCT03874494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2025-04-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Brexpiprazole

Brexpiprazole 2-4 mg/day

DRUG

Aripiprazole

Aripiprazole 10-20 mg/day

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Hongyan Zhang, PhD · Peking University Sixth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-27
Primary Completion
2021-08-06
Completion
2021-09-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874494 on ClinicalTrials.gov