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.

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