Status:
COMPLETED
Quetiapine in Social Anxiety Disorder
Lead Sponsor:
Duke University
Collaborating Sponsors:
AstraZeneca
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well...
Detailed Description
This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.
Eligibility Criteria
Inclusion
- adult outpatients 18-65 years of age
- primary diagnosis of social anxiety disorder, using DSM-IV criteria
- minimum CGI severity score of 4 at baseline
- minimum BSPS score of 20 at baseline
- written informed consent
- negative serum pregnancy test for women of childbearing potential
Exclusion
- current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
- any current primary anxiety disorder other than SAD or current primary depression
- history of substance abuse or dependence with the last 6 months
- suicide risk or serious suicide attempt within the last year
- clinically significant medical condition or laboratory abnormality
- women of childbearing potential who are unwilling to practice an acceptable method of contraception
- concomitant medication use for psychotropic purposes
- history of hypersensitivity to quetiapine
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00215254
Start Date
March 1 2004
End Date
February 1 2006
Last Update
December 19 2006
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705