Actively Recruiting
Phase 3 Global Study of SEP-363856 Fixed Doses Versus Placebo in Adults with Generalized Anxiety Disorder
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-08-12
576
Participants Needed
3
Research Sites
1 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a global phase 3 clinical trial to evaluate how well fixed doses of SEP-363856 work and how safe and tolerable they are for adults aged 18 and older with generalized anxiety disorder GAD. This randomized, double-blind, placebo-controlled study compares two doses of SEP-363856 50 mg and 75 mg per day against a placebo over an 8-week period. Participants are assigned to one of three groups one receives 50 mg of SEP-363856 daily, another starts with 50 mg daily for three days then increases to 75 mg daily up to day 56, and the third group receives a placebo daily for 56 days. All treatments are taken orally once a day. The study is designed to assess the treatment effects over this 8-week duration. During the study, participants will have assessments including evaluations of anxiety symptoms using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression-Severity CGI-S score at the start and end of the study. Researchers will monitor participants response to treatment, safety, and tolerability. The primary outcome is the change in HAM-A total score from baseline to week 8, and secondary outcomes include symptom severity and proportion of responders. The total participation duration is approximately 8 weeks.
CONDITIONS
Brief Title
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
Research Team
O
Otsuka Call Center
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