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

Inclusion Criteria:

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

• Patients with a diagnosis of schizophrenia based on DSM-5® (295.90) (multipleepisodes, currently in acute episode) and confirmed by the Mini InternationalNeuropsychiatric Interview (M.I.N.I.) at the time of informed consent

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

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

• Patients who were treated with antipsychotics at appropriate doses for appropriatedurations for the most recent acute episode and who are considered to have respondedto the antipsychotics (excluding clozapine)

• Patients who experienced a recurrence or exacerbation of symptoms during anantipsychotic-free period

• Patients who have been fully informed of and understand the objectives, procedures,risks, and expected medicinal benefits of the trial and are able to provide writteninformed consent prior to initiation of any trial-related procedures

Exclusion Criteria:

<Regarding indication>

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

• Patients who are considered resistant/refractory to antipsychotic treatment Patientswho are "unresponsive to medication with 2 or more antipsychotics at effective dosesfor a sufficiently long duration (6 weeks)" will be deemed resistant/refractory toantipsychotic treatment.

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

• Patients experiencing acute depressive symptoms within 30 days prior to informedconsent that, in the judgment of the investigator, require treatment with anantidepressant

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

• Patients who answered "yes" to Question 4 "Active Suicidal Ideation with SomeIntent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideationwith Specific Plan and Intent" regarding 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 2years) or at baseline (since the last assessment)

• Patients who present a serious risk of suicide based on the judgment of theinvestigator

• Patients presenting tardive dyskinesia at the time of informed consent, asdetermined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormalmovements) of the AIMS at screening or at baseline

• Patients with a score of 5 (severe akathisia) in the BARS global clinical assessmentof akathisia at screening or at baseline

• Patients who meet either of the following criteria between 30 days before screeningand the start of screening*

• Not including the start date of screening

1. Received 2 or more antipsychotics, each at doses equivalent to ≥ 600mg/day of chlorpromazine
2. Received a mean daily dose equivalent to > 800 mg/day**,*** ofchlorpromazine '**If multiple antipsychotics are taken in the same day, this is to be thecombined equivalent dose. ***This does not include administration of antipsychotic medication atdoses equivalent to less than 100 mg/day of chlorpromazine, which are notexpected to have any antipsychotic effect. Chlorpromazine equivalent dosesare based on Equivalent Conversion Table for Antipsychotics, as specifiedseparately.

• Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar IIdisorder, general anxiety disorder, obsessive-compulsive disorder, post-traumaticstress disorder, dementia or mild neurocognitive disorder, personality disorder,etc) based on DSM-5®. However, this exclusion does not apply to the following:

• Caffeine- or tobacco-related disorders

• Patients who have met the DSM-5® diagnostic criteria for substance-related oraddictive disorder, including alcohol and benzodiazepines but excluding caffeine andtobacco, within 180 days before commencement of investigational medicinal product (IMP) administration

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

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

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