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Trial record 1 of 1 for:    NCT01316302
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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Medical Research Network

Tracking Information
First Submitted Date  ICMJE March 14, 2011
First Posted Date  ICMJE March 16, 2011
Results First Submitted Date  ICMJE September 30, 2014
Results First Posted Date  ICMJE October 8, 2014
Last Update Posted Date October 17, 2016
Study Start Date  ICMJE April 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score [ Time Frame: Baseline to study endpoint (Week 12) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
Official Title  ICMJE A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE
  • Drug: Pristiq
    Flexible dose, 50-100mg QD, for 12 weeks.
    Other Name: desvenlafaxine
  • Drug: Placebo
    Matching placebo, taken QD for 12 weeks.
Study Arms  ICMJE
  • Experimental: Pristiq
    Flexible dose, 50-100mg QD
    Intervention: Drug: Pristiq
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2014)
63
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2011)
60
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01316302
Other Study ID Numbers  ICMJE PF2010SAD
WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Medical Research Network
Study Sponsor  ICMJE The Medical Research Network
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Michael R. Liebowitz, MD The Medical Research Network
PRS Account The Medical Research Network
Verification Date August 2016

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