A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder
Launched by OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. · Feb 6, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called SEP-363856 to see how well it works and how safe it is for adults with Generalized Anxiety Disorder (GAD). GAD is a condition where people feel excessive worry or anxiety about various aspects of life. The trial is open to both men and women aged 18 to 65 who have been diagnosed with GAD. Participants will need to be willing to follow the study’s procedures and attend scheduled visits.
If you join the study, you could be involved for about 12 weeks. While the trial is taking place at around 50 centers worldwide, there will also be additional locations specifically in Japan. It's important to note that individuals with certain other mental health conditions, those who have not responded to multiple antidepressant treatments, or those with significant medical issues may not be eligible to participate. This study aims to provide valuable information about a potential new option for treating GAD, so your participation could help advance understanding and treatment of this condition.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria: (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.
- • Exclusion Criteria: (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.
About Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc. is a leading biopharmaceutical company dedicated to advancing innovative treatments for unmet medical needs. As a subsidiary of Otsuka Pharmaceutical Co., Ltd., the organization focuses on the research, development, and commercialization of novel therapies across various therapeutic areas, including psychiatry, neurology, and oncology. With a commitment to scientific excellence and patient-centric solutions, Otsuka Pharmaceutical Development & Commercialization leverages cutting-edge technology and collaborative partnerships to enhance healthcare outcomes and improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oklahoma City, Oklahoma, United States
Redlands, California, United States
Brooklyn, New York, United States
Chicago, Illinois, United States
Cedarhurst, New York, United States
Sherman Oaks, California, United States
Barcelona, , Spain
Cherry Hill, New Jersey, United States
Oceanside, California, United States
Dallas, Texas, United States
Boston, Massachusetts, United States
Saint Charles, Missouri, United States
Madrid, , Spain
Tartu, , Estonia
Oulu, , Finland
Malmö, , Sweden
Alcorcón, Madrid, Spain
Culver City, California, United States
Bratislava, , Slovakia
Pleven, , Bulgaria
New York, New York, United States
Jacksonville, Florida, United States
Allentown, Pennsylvania, United States
Rimavská Sobota, , Slovakia
Tallinn, , Estonia
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Helsinki, , Finland
North Canton, Ohio, United States
Orlando, Florida, United States
Watertown, Massachusetts, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Upland, California, United States
Boston, Massachusetts, United States
Austin, Texas, United States
Huntsville, Alabama, United States
Miami, Florida, United States
Huntsville, Alabama, United States
Fukuoka Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Kitakyushu Shi, Fukuoka Ken, Japan
Kurume Shi, Fukuoka Ken, Japan
Meguro Ku, Tokyo To, Japan
Setagaya Ku, Tokyo To, Japan
Setagaya Ku, Tokyo To, Japan
Temecula, California, United States
Naha Shi, Okinawa Ken, Japan
Torrance, California, United States
Tampa, Florida, United States
New York, New York, United States
Alcorcón, Madrid, Spain
Sapporo Shi, Hokkaido, Japan
New York, New York, United States
North Canton, Ohio, United States
Aleksandar Stamboliyski Blvd.,, Plovdiv, Bulgaria
Makedonia Str., Ground Floor, Plovdiv, Bulgaria
Dr. Lyuben Russev Str., Sofia, Bulgaria
Klisura Str., Fl. 2, Sofia, Bulgaria
Nishava Str.,, Sofia, Bulgaria
Ood 17, Dimitar Manov Str.,, Sofia, Bulgaria
Slivnitsa Blvd., Sofia, Bulgaria
Republika Blvd., Mc Mladost, 3rd Floor, Varna, Bulgaria
Tallinn, , Estonia
Annankatu 32, Helsinki, Finland
Asemakatu 46 B 23, Kuopio, Finland
Isokatu 8 B 8, Oulu, Finland
Ltainenkatu, Tampere, Finland
Helsinki, , Finland
Hlavna 68, Kosice, Slovakia
Dobsinskeho 4861, Rimavska Sobota, Slovakia
Bratislava, Ruzinovska, Slovakia
Vegagatan 8, Stockholm, Sweden
Gothenburgh, , Sweden
Lund, , Sweden
Raja 31, Tartu, Estonia
M. R. Stefanika 2427, Vranov Nad Toplou, Slovakia
Bernolákova 24 953 01, Zlaté Moravce, Slovakia
Avda. Poeta Muñoz Rojas, S/N Antequera, Málaga, Spain
Föreningsgatan 26, Malmö,, , Sweden
Chikugo Shi, Fukuoka Ken, Japan
Kure Shi, Hiroshima Ken, Japan
Urasoe Shi, Okinawa Ken, Japan
Barcelona, , Spain
Langreo, Asturias, Spain
Sapporo Shi, Hokkaido, Japan
Marlton, New Jersey, United States
Madrid, , Spain
Phoenix, Arizona, United States
Sofia, Plovdiv, Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Kuopio, Savo, Finland
Helsinki, , Finland
Tampere, , Finland
Košice, Kosice, Slovakia
Rimavská Sobota, Rimavska Sobota, Slovakia
Vranov Nad Topľou, Vranov Nad Toplou, Slovakia
Zlaté Moravce, , Slovakia
Málaga, , Spain
Stockholm, , Sweden
Sofia, , Bulgaria
Barcelona, , Spain
Savannah, Georgia, United States
Huntsville, Alabama, United States
Oceanside, California, United States
Temecula, California, United States
Torrance, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Cherry Hill, New Jersey, United States
Cedarhurst, New York, United States
New York, New York, United States
North Canton, Ohio, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Sofia, Plovdiv, Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Varna, , Bulgaria
Tallinn, , Estonia
Tartu, , Estonia
Kuopio, Savo, Finland
Helsinki, , Finland
Helsinki, , Finland
Oulu, , Finland
Tampere, , Finland
Chikugo Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Kitakyushu Shi, Fukuoka Ken, Japan
Kurume Shi, Fukuoka Ken, Japan
Kure Shi, Hiroshima Ken, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Naha Shi, Okinawa Ken, Japan
Urasoe Shi, Okinawa Ken, Japan
Meguro Ku, Tokyo To, Japan
Setagaya Ku, Tokyo To, Japan
Setagaya Ku, Tokyo To, Japan
Bratislava, , Slovakia
Košice, , Slovakia
Rimavská Sobota, , Slovakia
Vranov Nad Topľou, , Slovakia
Zlaté Moravce, , Slovakia
Langreo, Asturias, Spain
Alcorcón, Madrid, Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Göteborg, , Sweden
Lund, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Málaga, , Spain
Huntsville, Alabama, United States
Culver City, California, United States
Oceanside, California, United States
Redlands, California, United States
Temecula, California, United States
Torrance, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Cherry Hill, New Jersey, United States
Cedarhurst, New York, United States
New York, New York, United States
New York, New York, United States
North Canton, Ohio, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Sofia, Plovdiv, Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Varna, , Bulgaria
Tallinn, , Estonia
Tartu, , Estonia
Kuopio, Savo, Finland
Helsinki, , Finland
Helsinki, , Finland
Oulu, , Finland
Tampere, , Finland
Chikugo Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Kitakyushu Shi, Fukuoka Ken, Japan
Kurume Shi, Fukuoka Ken, Japan
Kure Shi, Hiroshima Ken, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Naha Shi, Okinawa Ken, Japan
Urasoe Shi, Okinawa Ken, Japan
Meguro Ku, Tokyo To, Japan
Setagaya Ku, Tokyo To, Japan
Setagaya Ku, Tokyo To, Japan
Bratislava, , Slovakia
Košice, , Slovakia
Rimavská Sobota, , Slovakia
Vranov Nad Topľou, , Slovakia
Zlaté Moravce, , Slovakia
Langreo, Asturias, Spain
Alcorcón, Madrid, Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Göteborg, , Sweden
Lund, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Sherman Oaks, California, United States
Sherman, California, United States
Upland, California, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Warrenville, Illinois, United States
Boston, Massachusetts, United States
Saint Charles, Missouri, United States
Brooklyn, New York, United States
Mount Kisco, New York, United States
Oklahoma City, Oklahoma, United States
Draper, Utah, United States
Sherman, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Warrenville, Illinois, United States
Cherry Hill, New Jersey, United States
Mount Kisco, New York, United States
Oklahoma City, Oklahoma, United States
Austin, Texas, United States
Draper, Utah, United States
Sofia, Plovdiv, Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Varna, , Bulgaria
Helsinki, , Finland
Tampere, , Finland
Meguro Ku, Tokyo To, Japan
Košice, , Slovakia
Vranov Nad Topľou, , Slovakia
Zlaté Moravce, , Slovakia
Barcelona, , Spain
Göteborg, , Sweden
Lund, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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