A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

NCT ID: NCT05729373

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2025-09-26

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 .

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SEP-363856

dosed once daily tablet

Group Type: EXPERIMENTAL

SEP-363856

Intervention Type: DRUG

once daily tablet

Placebo

dosed once daily tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

once daily tablet

Interventions

SEP-363856

once daily tablet

Intervention Type: DRUG

Placebo

once daily tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

California Neuroscience Research, LLC

Sherman, California, United States

Schuster Medical Research Institute

Sherman Oaks, 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

American Medical Research, Inc.

Warrenville, Illinois, United States

Copley Clinical

Boston, Massachusetts, United States

Boston Clinical Trials

Boston, Massachusetts, 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

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, Northern Savonia, 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, Japan

Hiro Mental Clinic

Fukuoka, Fukuoka, Japan

Shinseikai Kaku Mental Clinic

Fukuoka, Fukuoka, Japan

Mental Clinic Sakurazaka

Fukuoka, Fukuoka, Japan

Kokura Mental Clinic

Kitakyushu-shi, Fukuoka, Japan

Hirota Clinic

Kurume-shi, Fukuoka, Japan

Hayakawa Clinic

Kure-shi, Hiroshima, Japan

Higashi-Sapporo Mental Clinic

Sapporo, Hokkaido, Japan

Shimode Mental Clinic

Sapporo, Hokkaido, Japan

Akari Clinic

Naha, Okinawa, Japan

Barclay Imuro Mental Clinic

Urasoe-shi, Okinawa, 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 Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Hospital Valle del Nalon

Langreo, Principality of Asturias, 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

Gothenburg, , Sweden

ProbarE- Lund

Lund, , Sweden

PharmaSite AB Malmö

Malmo, , Sweden

ProbarE- Stockholm

Stockholm, , Sweden

Countries

United States; Bulgaria; Estonia; Finland; Japan; Slovakia; Spain; Sweden

Other Identifiers

2022-502077-42-00

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031230152

Identifier Type: REGISTRY

Identifier Source: secondary_id

SEP361-226

Identifier Type: -

Identifier Source: org_study_id