12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder|
- Change in the Liebowitz Social Anxiety Scale (LSAS) total score [ Time Frame: Baseline to study endpoint (Week 12) ] [ Designated as safety issue: No ]
- Clinical Global Impression of Improvement scale (CGI-I) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
- Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
- Change on the LSAS anxiety and avoidance subscales [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Flexible dose, 50-100mg QD
Flexible dose, 50-100mg QD, for 12 weeks.
Other Name: desvenlafaxine
Placebo Comparator: Placebo
Matching placebo, taken QD for 12 weeks.
Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.
|United States, New York|
|The Medical Research Network, LLC|
|New York, New York, United States, 10128|
|Principal Investigator:||Michael R. Liebowitz, MD||The Medical Research Network|