Quetiapine in Social Anxiety Disorder
Information source: Duke University
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Anxiety Disorder
Intervention: quetiapine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Jonathan Davidson, M.D., Principal Investigator, Affiliation: Duke University
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-tolerated for patients with social anxiety disorder.
Clinical Details
Official title:
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Brief Social Phobia Scale (BSPS)
Secondary outcome: Clinical Global Impressions of Severity (CGI-S)Clinical Global Impressions of Improvement (CGI-I) Social Phobia Inventory (SPIN) Hospital Anxiety and Depression Scale (HADS) Connor Davidson Resilience Scale (CD-RISC) Sheehan Disability Inventory (SDI) Barnes Akathisis Scale (BAS) Simpson-Angus Scale (SAS)
Detailed description:
This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27705, United States
Additional Information
Starting date:
March 2004
Ending date: February 2006
Last updated: December 18, 2006
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