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 ]Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
- Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.
- Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316302
|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|