Schizophrenia Clinical Trial
Official title:
A Phase III, Multicenter, Randomized, Double-blind, Active-Controlled Study (Aripiprazole Tablets) to Evaluate the Efficacy and Safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia
This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia. A total of approximately 370 subjects will be included in the study, and randomized to Brexpiprazole (2~4 mg/d) or Aripiprazole (10~20 mg/d) in a 1:1 ratio.
Screening Phase: It will begin when informed consent form (ICF) is signed and be a maximum of 14 days, to evaluate the inclusion/exclusion criteria, collect information such as demographic data, medical history, wash out previous antipsychotic agents and other prohibited concomitant medications. Double-blind Treatment Phase: It lasts 6 weeks; the purpose is to compare the efficacy and safety of Brexpiprazole with Aripiprazole in the treatment of adults with acute schizophrenia. Follow-up Phase: All subjects will be followed up for safety reasons via telephone contact or clinic visit 30 (+ 2) days after the last dose of investigational medicinal product, collecting safety information (adverse events and concomitant medication). ;
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