A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder
- Registration Number
- NCT05729373
- Brief Summary
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.
- Detailed Description
This is a multicenter, randomized, double-blind, parallel-group, flexible dose, outpatient study evaluating the efficacy and safety of SEP-363856 flexibly dosed (50 - 75 mg/day) versus placebo over an 8-week Treatment Period in subjects with GAD. This study is projected to randomize approximately 434 subjects to 2 treatment groups (SEP-363856 \[50 - 75 mg/day\] or placebo) in a 1:1 ratio.
Approximately 30 additional subjects (N = 15 per treatment group) are projected to enroll in the Japan Cohort. Treatment assignment will be stratified by country. Study drug will be taken at approximately the same time each evening at bedtime .
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 434
(list is not all inclusive)
- Male or female subject between 18 to 65 years of age.
- Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
- Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
(list is not all inclusive)
- Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
- Subjects who report an inadequate response to more than 3 antidepressant treatments
- Subject is at significant risk of harming self or others based on Investigator's judgment.
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
- Female subject who is pregnant, lactating, or plans to get pregnant during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEP-363856 SEP-363856 dosed once daily tablet Placebo Placebo dosed once daily tablet
- Primary Outcome Measures
Name Time Method Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint Week 8 The HAM-A scale consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point (0-4) scale, with higher scores indicating greater severity.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint Week 8 The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Trial Locations
- Locations (84)
American Medical Research, Inc.
🇺🇸Warrenville, Illinois, United States
Copley Clinical
🇺🇸Boston, Massachusetts, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
University of Alabama at Birmingham
🇺🇸Huntsville, Alabama, United States
IMA Clinical Research Phoenix
🇺🇸Phoenix, Arizona, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
California Neuroscience Research, LLC
🇺🇸Sherman, California, United States
Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
🇺🇸Temecula, California, United States
CenExel Collaborative Neuroscience Research
🇺🇸Torrance, California, United States
Pacific Clinical Research Management Group
🇺🇸Upland, California, United States
CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Combined Research Orlando
🇺🇸Orlando, Florida, United States
K2 Medical Research, LLC
🇺🇸Tampa, Florida, United States
CenExel iResearch Atlanta
🇺🇸Atlanta, Georgia, United States
Advanced Discovery Research LLC
🇺🇸Atlanta, Georgia, United States
NeuroTrials Research, Inc.
🇺🇸Atlanta, Georgia, United States
CenExel iResearch Savannah
🇺🇸Savannah, Georgia, United States
Uptown Research Institute, LLC
🇺🇸Chicago, Illinois, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Center for Emotional Fitness Site
🇺🇸Cherry Hill, New Jersey, United States
CenExel Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Bioscience Research, LLC
🇺🇸Mount Kisco, New York, United States
Berman Clinical
🇺🇸New York, New York, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
The Medical Research Network, L.L.C
🇺🇸New York, New York, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸North Canton, Ohio, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Paradigm Research Professionals, LLP
🇺🇸Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research, LLC
🇺🇸Allentown, Pennsylvania, United States
Psychiatry and Psychotherapy Partners Austin
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Cedar Clinical Research, Inc.
🇺🇸Draper, Utah, United States
Medical Center Mentalcare OOD
🇧🇬Sofia, Plovdiv, Bulgaria
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
Medical Center Spectar - Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
MHC - Sofia, EOOD
🇧🇬Sofia, Bulgaria
Medical Center "Sv.Naum"
🇧🇬Sofia, Bulgaria
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Medical Center Intermedica, OOD
🇧🇬Sofia, Bulgaria
DCC "Mladost M" - Varna, OOD Site #156
🇧🇬Varna, Bulgaria
DCC "Mladost M" - Varna, OOD Site #157
🇧🇬Varna, Bulgaria
Marienthali Kliinik
🇪🇪Tallinn, Estonia
Tartu University Hospital
🇪🇪Tartu, Estonia
Savon Psykiatripalvelu Oy
🇫🇮Kuopio, Savo, Finland
Aava Laakarikeskus - Aava Kamppi
🇫🇮Helsinki, Finland
Mederon Oy
🇫🇮Helsinki, Finland
Oulu Mentalcare Oy
🇫🇮Oulu, Finland
Satakunnan Psykiatripalvelu
🇫🇮Tampere, Finland
Uematsu Mental Clinic
🇯🇵Chikugo-shi, Fukuoka-Ken, Japan
Hiro Mental Clinic
🇯🇵Fukuoka-shi, Fukuoka-Ken, Japan
Shinseikai Kaku Mental Clinic
🇯🇵Fukuoka-Shi, Fukuoka-Ken, Japan
Mental Clinic Sakurazaka
🇯🇵Fukuoka-shi, Fukuoka-Ken, Japan
Kokura Mental Clinic
🇯🇵Kitakyushu-shi, Fukuoka-Ken, Japan
Hirota Clinic
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
Hayakawa Clinic
🇯🇵Kure-shi, Hiroshima-Ken, Japan
Higashi-Sapporo Mental Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Shimode Mental Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Akari Clinic
🇯🇵Naha-shi, Okinawa-Ken, Japan
Barclay Imuro Mental Clinic
🇯🇵Urasoe-shi, Okinawa-Ken, Japan
Senzoku Psychosomatic Medicine Clinic
🇯🇵Meguro-ku, Tokyo-To, Japan
Sangenjaya Nakamura Mental Clinic
🇯🇵Setagaya-ku, Tokyo-To, Japan
Sangenjaya Neurology- Psychosomatic Clinic
🇯🇵Setagaya-ku, Tokyo-To, Japan
MENTUM, s.r.o.
🇸🇰Bratislava, Slovakia
Epamed sro
🇸🇰Košice, Slovakia
PsychoLine s.r.o.
🇸🇰Rimavská Sobota, Slovakia
Crystal Comfort s.r.o.
🇸🇰Vranov Nad Topľou, Slovakia
BONA MEDIC, s.r.o.
🇸🇰Zlaté Moravce, Slovakia
Hospital Valle del Nalon
🇪🇸Langreo, Asturias, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcón, Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Institucion Hospitalaria Hestia Palau
🇪🇸Barcelona, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital de Antequera
🇪🇸Málaga, Spain
Sahlgrenska Universitetssjukhuset - Östra sjukhuset
🇸🇪Göteborg, Sweden
ProbarE- Lund
🇸🇪Lund, Sweden
PharmaSite AB Malmö
🇸🇪Malmö, Sweden
ProbarE- Stockholm
🇸🇪Stockholm, Sweden