Quetiapine in Social Anxiety Disorder

Duke University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Social Anxiety Disorder

Treatments: Drug: quetiapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00215254

5639-04-3R0

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind