Actively Recruiting
Comparing the Efficacy and Safety of SEP-363856 Versus Placebo in Adults with Generalized Anxiety Disorder in a Multicenter, Randomized, Double-Blind Trial
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-10-20
384
Participants Needed
11
Research Sites
1 weeks
Total Duration
AI-Summary
What This Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of a fixed dose of SEP-363856 compared to placebo in adults with generalized anxiety disorder GAD. This global, phase 3, randomized, double-blind, placebo-controlled trial aims to provide new information about treatment options for adults diagnosed with GAD. Participants are randomly assigned to receive either SEP-363856 or a matching placebo. Those in the active treatment group start with 50 mg of SEP-363856 daily for the first 3 days, then increase to 75 mg daily for the remainder of the 8-week treatment period. The placebo group receives a matching tablet daily for 8 weeks. Both treatments are taken orally once a day. During the study, participants undergo assessments that include evaluations of anxiety symptoms using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression-Severity CGI-S scale. Researchers monitor changes from baseline to week 8 in these scores to assess treatment impact. Safety and tolerability are also monitored throughout the trial. Participation lasts for the 8-week treatment period with regular visits as scheduled.
CONDITIONS
Brief Title
A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder
Research Team
O
Otsuka Call Center
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