Clinical Research Directory

Inclusion Criteria: * Participant is aged 18-65 years, inclusive, at screening. * Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening. * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria. * Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening. * Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\\Item 2 (P2; conceptual disorganization)\\Item 3 (P3; hallucinatory behavior)\\Item 6 (P6; suspiciousness/persecution). Exclusion Criteria: * Judged by the investigator as having treatment-resistant schizophrenia. * Patients with risk of violent or destructive behavior, or suicidal risk. * History or presence of clinically significant neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. * Received electroconvulsive therapy within 3 months prior to screening, or received systemic transcranial magnetic stimulation (TMS) therapy within 1 month prior to screening. * Used clozapine or long-acting antipsychotic medications within 6 months prior to screening, or within 5 half-lives of long-acting antipsychotic medications at screening, whichever is longer. * Previous inadequate response to adequate dose and duration of aripiprazole treatment (≥20 mg/day for at least 6 weeks). * History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome. * Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria. * History of severe allergic reactions. * Female patients who are pregnant, in puerperium, or lactating at screening or baseline. * History of drug abuse within 1 year prior to screening. * History of alcohol abuse within 6 months prior to screening.