12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316302
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : October 8, 2014
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
The Medical Research Network

March 14, 2011
March 16, 2011
September 30, 2014
October 8, 2014
October 17, 2016
April 2011
November 2012   (Final data collection date for primary outcome measure)
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.
Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score [ Time Frame: Baseline to study endpoint (Week 12) ]
Complete list of historical versions of study NCT01316302 on Archive Site
  • 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.
  • Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Baseline to Week 12 ]
  • Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Baseline to Week 12 ]
  • Change on the LSAS Anxiety and Avoidance Subscales [ Time Frame: Baseline to Week 12 ]
Not Provided
Not Provided
12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized 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).
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Social Anxiety Disorder
  • Drug: Pristiq
    Flexible dose, 50-100mg QD, for 12 weeks.
    Other Name: desvenlafaxine
  • Drug: Placebo
    Matching placebo, taken QD for 12 weeks.
  • Experimental: Pristiq
    Flexible dose, 50-100mg QD
    Intervention: Drug: Pristiq
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must give written informed consent prior to any study procedures.
  • Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator.
  • A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.
  • A total HAM-D score of less than 15 at the Screening visit.
  • CGI Severity score of 4 or greater at both Screening and Baseline visits.
  • Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.

Exclusion Criteria:

  • An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator.
  • Any history or complication of schizophrenia or bipolar disorder.
  • Any complication of body dysmorphic disorder.
  • Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.
  • Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.
  • Subjects scoring >2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
  • Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95.
  • Positive Urine Drug Screen at the Screening visit.
  • Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.
  • Any history or complication of cancer or malignant tumor.
  • Fluoxetine within 28 days of Baseline
  • MAO inhibitors within 14 days of Baseline - Any other psychotropics (including SSRIs, SNRIs, and benzodiazepines) within 14 days of Baseline. Zolpidem (Ambien®) PRN is allowed for insomnia if not taken more than 3 times per week.
  • Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy.
  • Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.
  • Treatment refractory GSAD
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. )
Not Provided
Not Provided
The Medical Research Network
The Medical Research Network
Principal Investigator: Michael R. Liebowitz, MD The Medical Research Network
The Medical Research Network
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP