To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.

Inclusion Criteria:

• Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent
• Patients who are able to be hospitalized for the protocol-defined hospitalization period
• Patients with a body mass index [BMI = body weight (kg)/height (m)²] of 18.5 kg/m² or higher and lower than 35.0 kg/m² at screening
• Patients who, in the judgment of the investigator, have stable psychotic symptoms maintained by administration of an antipsychotic within the dosing range indicated below, before commencement of IMP administration [Upper limit of dose and regimen] Antipsychotic medication comprising no more than 2 active components, and a daily dose equivalent to ≤600 mg/day of chlorpromazine
• Patients who are able to finish the high-fat meal specified in this protocol within 20 minutes

Exclusion Criteria:

• Patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial

• 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 investigational medicinal product (IMP) administration

• 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 C-SSRS suicidal ideation at screening (for the past 6 months) or at the Period 1 baseline examination (since the last assessment)
  • Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at the Period 1 baseline examination (since the last assessment)
  • Patients who present a serious risk of suicide based on the judgment of the investigator

• Patients who have previously undergone gastrointestinal surgery that could affect PK evaluation

• 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 PK assessments.

• Patients who are using clozapine at the time of informed consent

• Patients whose clinical symptoms have worsened to the point where use of prohibited concomitant therapy or medication is required during the washout period for prior medication

• Patients whose cytochrome P450 2D6 (CYP2D6) phenotype is judged to be either poor metabolizers (PM) or Unknown based on the results of CYP2D6 genotyping at screening

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Safety analysis set, which included all randomized patients who received the study medication

Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days.

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.