A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

Inclusion Criteria:

New Subjects

• 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

• Patients at least 18 years of age and below the age of 75 at the time of informedconsent

• Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informedconsent

• Patients who are receiving treatment with antipsychotics (other than clozapine), whoare considered to require maintenance therapy using antipsychotics, and for whommonotherapy with the brexpiprazole QW formulation and outpatient management areconsidered feasible. Hospitalization for washout from any previously used drugsspecified as prohibited concomitant drugs or hospitalization for symptom managementimmediately after the start of IMP administration will be allowed at the discretionof the investigator. Hospitalization for social reasons (eg, homelessness or needfor shelter that is unrelated to the patient's psychological condition) ispermitted.

Period 1:

• Patients for whom switching to monotherapy with the brexpiprazole QW formulationusing an add-on and taper-off method within 4 weeks is considered feasible

Period 2:

• Patients who are able to begin monotherapy with the brexpiprazole QW formulation (atan initial dose of 48 mg/week) Rollover Subjects

• 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

• Patients who have completed the 6-week double-blind treatment period in Trial 331-102-00062

• Patients for whom monotherapy with the brexpiprazole QW formulation and outpatientmanagement are considered feasible. Hospitalization for symptom managementimmediately after the start of IMP administration will be allowed at the discretionof the investigator. Hospitalization for social reasons (eg, homelessness or needfor shelter that is unrelated to the patient's psychological condition) ispermitted.

Exclusion Criteria:

New Subjects

• Patients who are considered resistant/refractory to antipsychotic treatment Patientswho are

• 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 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

1. 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 Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment)

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

3. 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 Abnormal Involuntary Movement Scale (AIMS) at screening or atbaseline

• 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 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 disorder

• 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 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 c+E97onsideredacceptable 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 judged by the investigator to be unsuitable for participation in the trialRollover Subjects

• 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.