12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
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|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|
|Actual Primary Completion Date :||November 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|