Actively Recruiting
Phase 3 Study of SEP-363856 Tablets for Treatment of Acute Psychosis in Adults With Schizophrenia
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-07-31
522
Participants Needed
73
Research Sites
1 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.
CONDITIONS
Brief Title
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Research Team
O
Otsuka Call Center
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