Quetiapine in Social Anxiety Disorder

Phase 2

Completed

• Conditions: Social Anxiety Disorder

• Registration Number: NCT00215254
• Lead Sponsor: Duke University

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-tolerated for patients with social anxiety disorder.

Detailed Description

This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Study Completion: 2006-02
• Status Verified: 2006-03
• Last Update Submitted: 2006-12-18
• Last Update Posted: 2006-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brief Social Phobia Scale (BSPS)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States