12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

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