12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Pristiq; Placebo
Intervention description: Flexible dose, 50-100mg QD, for 12 weeks.; Matching placebo, taken QD for 12 weeks.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Social Anxiety Disorder; Social Phobia; SAD

Summary:

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

Eligibility 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