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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

Brief Summary:
This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Pristiq Drug: Placebo Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : April 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Pristiq
Flexible dose, 50-100mg QD
Drug: Pristiq
Flexible dose, 50-100mg QD, for 12 weeks.
Other Name: desvenlafaxine

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo, taken QD for 12 weeks.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01316302

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United States, New York
The Medical Research Network, LLC
New York, New York, United States, 10128
Sponsors and Collaborators
The Medical Research Network
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Principal Investigator: Michael R. Liebowitz, MD The Medical Research Network
Additional Information:
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Responsible Party: The Medical Research Network Identifier: NCT01316302    
Other Study ID Numbers: PF2010SAD
WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. )
First Posted: March 16, 2011    Key Record Dates
Results First Posted: October 8, 2014
Last Update Posted: October 17, 2016
Last Verified: August 2016
Keywords provided by The Medical Research Network:
Social Anxiety Disorder
Social Phobia
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs