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

• Status: Not yet recruiting
• Trial end date: 2025-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion

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 inclusvie)

• Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than Generalized Anxiety Disorder, that is the primary focus of treatment.

• 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.