COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-08
Study Completion:2025-09-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05729373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female subject between 18 to 65 years of age.
  2. * Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
  3. * 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.
  1. * 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.
  2. * Subjects who report an inadequate response to more than 3 antidepressant treatments
  3. * Subject is at significant risk of harming self or others based on Investigator's judgment.
  4. * 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.
  5. * Female subject who is pregnant, lactating, or plans to get pregnant during the study.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-08
Study Completion Date2025-09-26

Study Record Updates

Study Start Date2023-03-08
Study Completion Date2025-09-26

Terms related to this study

Keywords Provided by Researchers

  • Generalized Anxiety Disorder

Additional Relevant MeSH Terms

  • Generalized Anxiety Disorder