A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder
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
3 other identifiers
interventional
434
7 countries
77
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedOctober 10, 2025
October 1, 2025
2.6 years
February 6, 2023
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint
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.
Week 8
Secondary Outcomes (1)
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
Week 8
Study Arms (2)
SEP-363856
EXPERIMENTALdosed once daily tablet
Placebo
PLACEBO COMPARATORdosed once daily tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
University of Alabama at Birmingham
Huntsville, Alabama, 35801, United States
IMA Clinical Research Phoenix
Phoenix, Arizona, 85012, United States
ProScience Research Group
Culver City, California, 90230, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
Anderson Clinical Research
Redlands, California, 92374, United States
California Neuroscience Research, LLC
Sherman, California, 91403, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
Temecula, California, 92591, United States
CenExel Collaborative Neuroscience Research
Torrance, California, 90502, United States
Pacific Clinical Research Management Group
Upland, California, 91786, United States
CNS Healthcare
Jacksonville, Florida, 32256, United States
Combined Research Orlando
Orlando, Florida, 32803, United States
K2 Medical Research, LLC
Tampa, Florida, 33607, United States
CenExel iResearch Atlanta
Atlanta, Georgia, 30030, United States
Advanced Discovery Research LLC
Atlanta, Georgia, 30318, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328, United States
CenExel iResearch Savannah
Savannah, Georgia, 31405, United States
Uptown Research Institute, LLC
Chicago, Illinois, 60640, United States
American Medical Research, Inc.
Warrenville, Illinois, 60555, United States
Copley Clinical
Boston, Massachusetts, 02116, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
Midwest Research Group
Saint Charles, Missouri, 63304, United States
Center for Emotional Fitness Site
Cherry Hill, New Jersey, 08002, United States
CenExel Hassman Research Institute
Marlton, New Jersey, 08053, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Bioscience Research, LLC
Mount Kisco, New York, 10016, United States
Berman Clinical
New York, New York, 10029, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
The Medical Research Network, L.L.C
New York, New York, 10128, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Paradigm Research Professionals, LLP
Oklahoma City, Oklahoma, 73116, United States
Lehigh Center for Clinical Research, LLC
Allentown, Pennsylvania, 18104, United States
Psychiatry and Psychotherapy Partners Austin
Austin, Texas, 78737, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Cedar Clinical Research, Inc.
Draper, Utah, 84020, United States
Medical Center Mentalcare OOD
Sofia, Plovdiv, 4004, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
MHC - Sofia, EOOD
Sofia, 1000, Bulgaria
Medical Center "Sv.Naum"
Sofia, 1113, Bulgaria
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia, 1408, Bulgaria
Medical Center Hera EOOD
Sofia, 1510, Bulgaria
Medical Center Intermedica, OOD
Sofia, 1680, Bulgaria
DCC "Mladost M" - Varna, OOD Site #156
Varna, 9020, Bulgaria
DCC "Mladost M" - Varna, OOD Site #157
Varna, 9020, Bulgaria
Marienthali Kliinik
Tallinn, 11315, Estonia
Tartu University Hospital
Tartu, 50417, Estonia
Savon Psykiatripalvelu Oy
Kuopio, Northern Savonia, 70110, Finland
Aava Laakarikeskus - Aava Kamppi
Helsinki, 00100, Finland
Mederon Oy
Helsinki, 00100, Finland
Oulu Mentalcare Oy
Oulu, 90100, Finland
Satakunnan Psykiatripalvelu
Tampere, 33210, Finland
Uematsu Mental Clinic
Chikugo-shi, Fukuoka, 833-0041, Japan
Hiro Mental Clinic
Fukuoka, Fukuoka, 810-0004, Japan
Shinseikai Kaku Mental Clinic
Fukuoka, Fukuoka, 810-0022, Japan
Mental Clinic Sakurazaka
Fukuoka, Fukuoka, 810-0023, Japan
Kokura Mental Clinic
Kitakyushu-shi, Fukuoka, 802-0006, Japan
Hirota Clinic
Kurume-shi, Fukuoka, 830-0033, Japan
Hayakawa Clinic
Kure-shi, Hiroshima, 737-0111, Japan
Higashi-Sapporo Mental Clinic
Sapporo, Hokkaido, 003-0003, Japan
Shimode Mental Clinic
Sapporo, Hokkaido, 062-0922, Japan
Akari Clinic
Naha, Okinawa, 900-0004, Japan
Barclay Imuro Mental Clinic
Urasoe-shi, Okinawa, 901-2104, Japan
Senzoku Psychosomatic Medicine Clinic
Meguro-ku, Tokyo-To, 152-0012, Japan
Sangenjaya Nakamura Mental Clinic
Setagaya-ku, Tokyo-To, 154-0004, Japan
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, Tokyo-To, 154-0004, Japan
MENTUM, s.r.o.
Bratislava, 82007, Slovakia
Epamed sro
Košice, 040 01, Slovakia
PsychoLine s.r.o.
Rimavská Sobota, 97901, Slovakia
Crystal Comfort s.r.o.
Vranov nad Topľou, 9301, Slovakia
BONA MEDIC, s.r.o.
Zlaté Moravce, 95301, Slovakia
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Valle del Nalon
Langreo, Principality of Asturias, 33920, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025, Spain
Institucion Hospitalaria Hestia Palau
Barcelona, 8025, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital de Antequera
Málaga, 29200, Spain
Sahlgrenska Universitetssjukhuset - Östra sjukhuset
Gothenburg, 416 50, Sweden
ProbarE- Lund
Lund, 22222, Sweden
PharmaSite AB Malmö
Malmo, 21152, Sweden
ProbarE- Stockholm
Stockholm, 113 29, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2023
First Posted
February 15, 2023
Study Start
March 8, 2023
Primary Completion
September 26, 2025
Study Completion
September 26, 2025
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.