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

Exclusion Criteria

• •New Subjects
• •Patients who are considered resistant/refractory to antipsychotic treatment Patients who are
• •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 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
• •1. 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)
• •2. Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment)
• •3. Patients who present a serious risk of suicide based on the judgment of the investigator
• •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 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:
• •• Caffeine- or tobacco-related disorder
• •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 c+E97onsidered 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 judged by the investigator to be unsuitable for participation in the trial Rollover Subjects
• •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.