Status:
COMPLETED
Geodon for the Treatment of Refractory Social Anxiety Disorder
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 r...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00215150
Start Date
November 1 2004
End Date
July 1 2009
Last Update
October 31 2014
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27701
2
Duke University Medical Center
Durham, North Carolina, United States, 27710