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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medical Research Network
• Collaborator: Pfizer
• Treatments: Desvenlafaxine Succinate

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