Skip to main content
OpenTrials
Completed

NCT Number: NCT00215254

Quetiapine in Social Anxiety Disorder

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine

Drug

Primary outcomes

  1. Brief Social Phobia Scale (BSPS)

Secondary outcomes

  1. Clinical Global Impressions of Severity (CGI-S)

  2. Clinical Global Impressions of Improvement (CGI-I)

  3. Social Phobia Inventory (SPIN)

  4. Hospital Anxiety and Depression Scale (HADS)

  5. Connor Davidson Resilience Scale (CD-RISC)

  6. Sheehan Disability Inventory (SDI)

  7. Barnes Akathisis Scale (BAS)

  8. Simpson-Angus Scale (SAS)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Dec 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.