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Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia

NCT05325645 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-03-12

No results posted yet for this study

Summary

Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia

Conditions

  • Acute Schizophrenia

Interventions

DRUG

OPC-34712FUM/ Brexpiprazole fumarate

2 brexpiprazole QW tablets 24 mg (48 mg/dose) will be orally administered once weekly for 7weeks.(As an initial dose, one brexpiprazole QW tablet 24 mg and one placebo tablet will be orally administered (24 mg/dose))

DRUG

Placebo

Two placebo tablets will be orally administered once weekly for 7weeks.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takeshi Tsunoda · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-21
Primary Completion
2026-02-28
Completion
2026-03-31
FDA Drug
Yes

Countries

  • Japan

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Entities

Drugs

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 NCT05325645 on ClinicalTrials.gov