View Clinical Trial (Medical Research Study)

A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder

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Conditions:		Social Anxiety Disorder
Purpose:		This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).
Study Summary:		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.
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
NCT ID:		NCT01316302
Primary Contact:		Principal Investigator Michael R. Liebowitz, MD The Medical Research Network
Backup Contact:		N/A
Location Contact:		New York, New York 10128 United States There is no listed contact information for this specific location. Site Status: N/A

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