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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Medical Research Network
ClinicalTrials.gov Identifier:
NCT01316302
First received: March 14, 2011
Last updated: January 16, 2014
Last verified: January 2014

March 14, 2011
January 16, 2014
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01316302 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression of Improvement scale (CGI-I) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change on the LSAS anxiety and avoidance subscales [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01316302
PF2010SAD, WS1228302
No
The Medical Research Network
The Medical Research Network
Pfizer
Principal Investigator: Michael R. Liebowitz, MD The Medical Research Network
The Medical Research Network
January 2014

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