Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
Patients at least 18 years of age and below the age of 75 at the time of informed consent
Patients with a diagnosis of schizophrenia based on DSM-5® (295.90) (multiple episodes, currently in acute episode) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) 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 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 are "unresponsive to medication with 2 or more antipsychotics at effective doses for a sufficiently long duration (6 weeks)" will be deemed 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
Parallel
OPC-34712FUM/ Brexpiprazole fumarate
Drug2 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))
Placebo
DrugTwo placebo tablets will be orally administered once weekly for 7weeks.
Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at last visit of the double-blind period
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Otsuka Pharmaceutical Co., Ltd.
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator
