12-week study of pristiq (desvenlafaxine) social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: 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.

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

Keywords: social anxiety disorder social phobia sad