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NCT00215254 Clinical Trial

Quetiapine in Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00215254
Other study ID # 5639-04-3R0
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 20, 2005
Last updated December 18, 2006
Start date March 2004
Est. completion date February 2006

Study information
Verified date March 2006
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• quetiapine

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brief Social Phobia Scale (BSPS)
Secondary Clinical Global Impressions of Severity (CGI-S)
Secondary Clinical Global Impressions of Improvement (CGI-I)
Secondary Social Phobia Inventory (SPIN)
Secondary Hospital Anxiety and Depression Scale (HADS)
Secondary Connor Davidson Resilience Scale (CD-RISC)
Secondary Sheehan Disability Inventory (SDI)
Secondary Barnes Akathisis Scale (BAS)
Secondary Simpson-Angus Scale (SAS)
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