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, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who have been diagnosed with generalized anxiety disorder (GAD).Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- SEP-363856
Trial Overview
The study compares two fixed daily doses of the investigational drug SEP-363856 (50 mg and 75 mg) to a placebo. Participants are randomly assigned to one of three groups, and neither they nor the researchers know which treatment they're receiving.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 50 mg SEP-363856 tablet, orally, QD, from Days 1 to 3 and then 75 mg tablet from Days 4 to 56.
Participants will receive 50 milligrams (mg) SEP-363856 tablet, orally, once a day (QD) from Days 1 to 56.
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
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.