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

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Collaborator: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

• Patients at least 18 years of age and below the age of 65 at the time of informed consent

• Patients with a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5®) (multiple episodes, currently in acute episode) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) assessment for psychotic disorders at the time of informed consent

• Patients who are hospitalized, or judged to require hospitalization, for acute relapse of schizophrenia at the time of informed consent

• Patients whose current episode developed within 2 months prior to screening

• Patients with acute exacerbation of psychotic symptoms and a marked decline in daily functioning who meet all of the following criteria when the placebo administration period begins: a) PANSS total score of ≥ 70 b) Scores of ≥ 4 (moderate) for at least 2 of 4 PANSS items (Hallucinatory Behavior, Unusual Thought Content, Conceptual Disorganization, Suspiciousness) of ≥ 4 (moderate) c) CGI-S score of ≥ 4 (moderately ill)

• Patients who were treated with antipsychotics at appropriate doses (recommended doses for the treatment of schizophrenia indicated in the package insert of the drug provided by the manufacturer/distributor) for appropriate durations (at least 6 weeks) and who are considered to have responded to the antipsychotics (excluding clozapine) within 12 months prior to informed consent

• Patients who experienced a recurrence or exacerbation of symptoms during an antipsychotic-free period (excluding the current episode)

• Patients who are able to provide written informed consent prior to initiation of any trial-related procedures

Exclusion Criteria:

• Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator

• Patients who are considered resistant/refractory to antipsychotic treatment

• Patients who have a history of treatment with clozapine for schizophrenia

• Patients experiencing acute depressive symptoms within 30 days prior to informed consent that, in the judgment of the investigator, require treatment with an antidepressant

• Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior

• Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment)

• Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment)

• Patients who present a serious risk of suicide based on the judgment of the investigator or subinvestigatorinvestigator

• Patients presenting tardive dyskinesia at the time of informed consent, as determined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormal movements) of the Abnormal Involuntary Movement Scale (AIMS) at screening or at baseline

• Patients with a score of 5 (severe akathisia) in the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia at screening or at baseline

• Patients who meet eitherany of the following criteria between 30 days before screeningthe current hospitalization and the start of screeningthe day before hospitalization a) Received 2 or more antipsychotics, each at doses equivalent to ≥ 600 mg/day of chlorpromazine b) Received athe mean daily dose equivalent to > 800 mg/day of chlorpromazine

• Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on DSM-5®. However, this exclusion does not apply to the following: a) Caffeine- or tobacco-related disorders b) Disorders other than intellectual disability in the category of neurodevelopmental disorders

• Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of IMP administration

• Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and efficacy assessments.

• Patients with known hypersensitivity or intolerance to brexpiprazole or patients with confirmed resistance to brexpiprazole therapy. Patients who have received brexpiprazole to treat the current episode.

• Patients judged by the investigator to be unsuitable for participation in the trial."