SEP-363856 for Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with generalized anxiety disorder (GAD). Participants should be generally healthy aside from their anxiety and able to follow study procedures. People with other major mental health conditions or serious medical issues may not be eligible.Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- SEP-363856
Trial Overview
The study compares a fixed daily dose of SEP-363856 (75 mg) to a placebo over 8 weeks. Participants are randomly assigned to one of the two groups, and neither they nor the researchers know which treatment they're receiving.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive SEP-363856, 50 mg (Days 1 to 3) and 75 mg/day tablet, from Days 4 to 56, orally, QD.
Participants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University
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