RecruitingPhase 3NCT05325645

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

A Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Investigate the Efficacy and Safety of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia


Sponsor

Otsuka Pharmaceutical Co., Ltd.

Enrollment

450 participants

Start Date

Jul 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests a once-weekly injectable formulation of brexpiprazole — a medication used to treat schizophrenia and as an add-on for depression — to evaluate if the long-acting version is as effective and safe as daily oral doses. **You may be eligible if...** - You have schizophrenia or major depressive disorder being treated with brexpiprazole - You are currently stable on daily oral brexpiprazole - You are 18 or older - You consent to switch to the weekly injection formulation **You may NOT be eligible if...** - You have a history of non-adherence that cannot be managed - You are pregnant or planning pregnancy - You have severe liver disease - You have had a recent hospitalization for psychiatric crisis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOPC-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))

DRUGPlacebo

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


Locations(1)

Hayakawa Clinic

Kure-shi, Japan

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NCT05325645