Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: October 6, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Social Anxiety Disorder
Drug: Pristiq
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by The Medical Research Network:

Primary Outcome Measures:
  • Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score [ Time Frame: Baseline to study endpoint (Week 12) ] [ Designated as safety issue: No ]
    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:
  • Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.

  • Change on the LSAS Anxiety and Avoidance Subscales [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316302

Locations
United States, New York
The Medical Research Network, LLC
New York, New York, United States, 10128
Sponsors and Collaborators
The Medical Research Network
Pfizer
Investigators
Principal Investigator: Michael R. Liebowitz, MD The Medical Research Network
  More Information

Additional Information:
No publications provided

Responsible Party: The Medical Research Network
ClinicalTrials.gov Identifier: NCT01316302     History of Changes
Other Study ID Numbers: PF2010SAD, WS1228302
Study First Received: March 14, 2011
Results First Received: September 30, 2014
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by The Medical Research Network:
Social Anxiety Disorder
Social Phobia
SAD

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes
O-desmethylvenlafaxine
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014