Geodon for the Treatment of Refractory Social Anxiety Disorder (SAD)

The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

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.

• Drug: Ziprasidone
  Sertraline augmentation with ziprasidone
  Other Name: Geodon
• Drug: Sertraline
  Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
  Other Name: Zoloft

• Open Label Treatment
  8 weeks of open label treatment with sertraline
  Intervention: Drug: Sertraline
• Randomization Ziprasidone
  8 weeks of treatment with sertraline augmented with ziprasidone
  Interventions:

  • Drug: Ziprasidone
  • Drug: Sertraline
• Randomization Placebo
  8 weeks of treatment with sertraline augmented by placebo
  Intervention: Drug: Sertraline

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