12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
|ClinicalTrials.gov Identifier: NCT01316302|
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : October 8, 2014
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder||Drug: Pristiq Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder|
|Study Start Date :||April 2011|
|Primary Completion Date :||November 2012|
|Study Completion Date :||December 2012|
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.
- Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score [ Time Frame: Baseline to study endpoint (Week 12) ]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 ]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.
- Patient Global Impression of Change [ Time Frame: Baseline to study endpoint (Week 12) ]Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|