Actively Recruiting
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2025-03-12
450
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
O
Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor
O
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
CONDITIONS
Official Title
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to under 65 years at the time of consent
- Diagnosis of schizophrenia with multiple episodes, currently in an acute episode, confirmed by DSM-5 and M.I.N.I.
- Hospitalized or judged to require hospitalization for acute schizophrenia relapse
- Current episode developed within 2 months before screening
- Treated with appropriate doses and durations of antipsychotics (excluding clozapine) for the recent episode and considered responsive
- Experienced symptom recurrence or worsening during a period without antipsychotic treatment
- Fully informed about and able to consent to the trial objectives, procedures, risks, and benefits
You will not qualify if you...
- First episode of schizophrenia based on investigator judgment
- Resistant or refractory to antipsychotic treatment, defined as unresponsive to 2 or more antipsychotics at effective doses for at least 6 weeks
- History of clozapine treatment for schizophrenia
- Acute depressive symptoms within 30 days before consent requiring antidepressant treatment
- Suicidal ideation or behavior as defined by C-SSRS criteria at screening or baseline, or judged at serious suicide risk by investigator
- Moderate or severe tardive dyskinesia at screening or baseline
- Severe akathisia at screening or baseline
- Received 2 or more antipsychotics at doses equal to or above 600 mg/day chlorpromazine equivalent, or mean daily dose above 800 mg/day chlorpromazine equivalent within 30 days before screening
- Diagnosis of other mental disorders besides schizophrenia (except caffeine or tobacco-related disorders)
- Substance-related or addictive disorder (excluding caffeine and tobacco) within 180 days before starting investigational product
- Clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders that interfere with safety or efficacy
- Known hypersensitivity or intolerance to brexpiprazole or confirmed resistance to brexpiprazole therapy
- Judged unsuitable for trial participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hayakawa Clinic
Kure-shi, Japan
Actively Recruiting
Research Team
D
Drug Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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