A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
Status: Completed
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham
Huntsville
Arizona
IMA Clinical Research Phoenix
Phoenix
California
ProScience Research Group
Culver City
Excell Research, Inc.
Oceanside
Anderson Clinical Research
Redlands
California Neuroscience Research, LLC
Sherman
Schuster Medical Research Institute
Sherman Oaks
Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
Temecula
CenExel Collaborative Neuroscience Research
Torrance
Pacific Clinical Research Management Group
Upland
Florida
CNS Healthcare
Jacksonville
Combined Research Orlando
Orlando
K2 Medical Research, LLC
Tampa
Georgia
Advanced Discovery Research LLC
Atlanta
CenExel iResearch Atlanta
Atlanta
NeuroTrials Research, Inc.
Atlanta
CenExel iResearch Savannah
Savannah
Illinois
Uptown Research Institute, LLC
Chicago
American Medical Research, Inc.
Warrenville
Massachusetts
Boston Clinical Trials
Boston
Copley Clinical
Boston
Adams Clinical
Watertown
Missouri
Midwest Research Group
Saint Charles
New Jersey
Center for Emotional Fitness Site
Cherry Hill
CenExel Hassman Research Institute
Marlton
New York
Social Psychiatry Research Institute
Brooklyn
Neurobehavioral Research, Inc.
Cedarhurst
Bioscience Research, LLC
Mount Kisco
Berman Clinical
New York
Manhattan Behavioral Medicine
New York
The Medical Research Network, L.L.C
New York
Ohio
Neuro-Behavioral Clinical Research, Inc.
North Canton
Oklahoma
Paradigm Research Professionals, LLP
Oklahoma City
Sooner Clinical Research
Oklahoma City
Pennsylvania
Lehigh Center for Clinical Research, LLC
Allentown
Texas
Psychiatry and Psychotherapy Partners Austin
Austin
FutureSearch Trials of Dallas, LP
Dallas
Utah
Cedar Clinical Research, Inc.
Draper
Other Locations
Bulgaria
Medical Center Medconsult Pleven OOD
Pleven
DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan, OOD
Sofia
Medical Center Hera EOOD
Sofia
Medical Center Intermedica, OOD
Sofia
Medical Center Mentalcare OOD
Sofia
Medical Center Sv.Naum
Sofia
MHC - Sofia, EOOD
Sofia
DCC Mladost M - Varna, OOD Site #156
Varna
DCC Mladost M - Varna, OOD Site #157
Varna
Estonia
Marienthali Kliinik
Tallinn
Tartu University Hospital
Tartu
Finland
Aava Laakarikeskus - Aava Kamppi
Helsinki
Mederon Oy
Helsinki
Savon Psykiatripalvelu Oy
Kuopio
Oulu Mentalcare Oy
Oulu
Satakunnan Psykiatripalvelu
Tampere
Japan
Uematsu Mental Clinic
Chikugo-shi
Hiro Mental Clinic
Fukuoka
Mental Clinic Sakurazaka
Fukuoka
Shinseikai Kaku Mental Clinic
Fukuoka
Kokura Mental Clinic
Kitakyushu-shi
Hayakawa Clinic
Kure-shi
Hirota Clinic
Kurume-shi
Senzoku Psychosomatic Medicine Clinic
Meguro-ku
Akari Clinic
Naha
Higashi-Sapporo Mental Clinic
Sapporo
Shimode Mental Clinic
Sapporo
Sangenjaya Nakamura Mental Clinic
Setagaya-ku
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku
Barclay Imuro Mental Clinic
Urasoe-shi
Slovakia
MENTUM, s.r.o.
Bratislava
Epamed sro
Košice
PsychoLine s.r.o.
Rimavská Sobota
Crystal Comfort s.r.o.
Vranov Nad Topľou
BONA MEDIC, s.r.o.
Zlaté Moravce
Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón
Hospital de la Santa Creu i Sant Pau
Barcelona
Institucion Hospitalaria Hestia Palau
Barcelona
Hospital Valle del Nalon
Langreo
Hospital Universitario Infanta Leonor
Madrid
Hospital de Antequera
Málaga
Sweden
Sahlgrenska Universitetssjukhuset - Östra sjukhuset
Gothenburg
ProbarE- Lund
Lund
PharmaSite AB Malmö
Malmo
ProbarE- Stockholm
Stockholm
Time Frame
Start Date: 2023-03-08
Completion Date: 2025-09-26
Participants
Target number of participants: 434
Treatments
Experimental: SEP-363856
dosed once daily tablet
Placebo_comparator: Placebo
dosed once daily tablet
Related Therapeutic Areas
Sponsors
Leads: Otsuka Pharmaceutical Development & Commercialization, Inc.