A PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VENLAFAXINE IN JAPANESE OUTPATIENTS WITH GENERALIZED ANXIETY DISORDER
- Conditions
- GENERALIZED ANXIETY DISORDER
- Registration Number
- JPRN-jRCT2031220156
- Lead Sponsor
- Kitano Madoka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 336
Participants with a diagnosis of GAD based on the DSM-5 diagnostic criteria, which is confirmed by the Mini International Neuropsychiatric Interview (MINI).
-Participants with a HAM-A total score >= 20 and CGI-S score >= 4 both at the initiation of the screening period and at baseline.
-Participants with a GAD-7 total score >= 10 both at the initiation of the screening period and at baseline.
-Participants with a Montgomery-Asberg Depression Rating Scale (MADRS) total score >= 20 at the initiation of the screening period or at baseline.
-Participants with an improvement of 20% or more on the HAM-A total score at baseline, compared with the score at the initiation of the placebo lead-in period.
-Participants with known hypersensitivity to venlafaxine or desvenlafaxine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the change in the HAM-A total score from baseline to treatment completion or discontinuation.
- Secondary Outcome Measures
Name Time Method