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

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.

Conditions

Generalized Anxiety Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Generalized Anxiety Disorder
Intervention / Treatment

-

Contacts and Locations

Huntsville

University of Alabama at Birmingham Site #116, Huntsville, Alabama, United States, 35801

Oceanside

Excell Research, Inc. Site #106, Oceanside, California, United States, 92056

Temecula

Viking Pharmaceutical Trials Inc. dba Viking Clinical Research Site#110, Temecula, California, United States, 92591

Torrance

CenExel Collaborative Neuroscience Research Site #113, Torrance, California, United States, 90502

Tampa

K2 Medical Research, LLC Site #114, Tampa, Florida, United States, 33607

Atlanta

NeuroTrials Research, Inc. Site #103, Atlanta, Georgia, United States, 30328

Chicago

Uptown Research Institute, LLC Site #107, Chicago, Illinois, United States, 60640

Boston

Boston Clinical Trials Site#112, Boston, Massachusetts, United States, 02131

Cherry Hill

Center for Emotional Fitness Site #104, Cherry Hill, New Jersey, United States, 08002

Cedarhurst

Neurobehavioral Research, Inc. Site #100, Cedarhurst, New York, United States, 11516

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Otsuka Pharmaceutical Development & Commercialization, Inc.,

Study Record Dates

2025-02-08