A Clinical Study that will measure how well SEP-363856 works and how safe it is in adults with Generalized Anxiety Disorder

Phase 1

Recruiting

Conditions: generalised anxiety disorder
MedDRA version: 21.1Level: PTClassification code: 10018075Term: Generalised anxiety disorder Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: CTIS2022-502077-42-00

Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 434

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 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 judgement., 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of flexible doses of SEP-363856 (50 – 75 mg/day) compared with placebo in subjects with GAD as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score;Secondary Objective: To evaluate the efficacy of flexible doses of SEP-363856 (50 - 75 mg/day) compared with placebo in subjects with GAD as measured by the Clinical Global Impression-Severity (CGI-S) score;Primary end point(s): Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint.

Secondary Outcome Measures