Geodon for the Treatment of Refractory Social Anxiety Disorder

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: Ziprasidone
* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Label Treatment<br>8 weeks of open label treatment with sertraline | Drug: Sertraline<br>* Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase<br>* Other names: Zoloft;|
| Other: Randomization Ziprasidone<br>8 weeks of treatment with sertraline augmented with ziprasidone | Drug: Ziprasidone<br>* Sertraline augmentation with ziprasidone<br>* Other names: Geodon;Drug: Sertraline<br>* Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase<br>* Other names: Zoloft;|
| Other: Randomization Placebo<br>8 weeks of treatment with sertraline augmented by placebo | Drug: Sertraline<br>* Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase<br>* Other names: Zoloft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Social Phobia Scale(BSPS) | An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items. | Baseline, 8 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAD, anxiety disorder, ziprasidone, sertraline, antidepressant, antipsychotic