Geodon for the Treatment of Refractory Social Anxiety Disorder

This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Inclusion criteria

• adults 18-65 years of age
• primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria
• minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline
• minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline
• written informed consent
• negative serum pregnancy test for women of childbearing potential
• normal EKG

Exclusion criteria

• current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
• any current primary anxiety disorder other than SAD
• current primary depression
• history of substance abuse or dependence within the last 3 months
• suicide risk or serious suicide attempt within the last year
• clinically significant medical condition or laboratory or EKG abnormality
• women of childbearing potential who are unwilling to practice an acceptable method of contraception
• patients needing concurrent use of psychotropic medications
• history of hypersensitivity to sertraline or ziprasidone
• recent (less than 2 months) initiation of psychotherapy for SAD
• history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic
• patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra