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Quetiapine in Social Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00215254
First received: September 20, 2005
Last updated: December 18, 2006
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Social Anxiety Disorder
Drug: quetiapine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Brief Social Phobia Scale (BSPS)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 15
Study Start Date: March 2004
Estimated Study Completion Date: February 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215254

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
AstraZeneca
Investigators
Principal Investigator: Jonathan Davidson, M.D. Duke University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215254     History of Changes
Other Study ID Numbers: 5639-04-3R0
Study First Received: September 20, 2005
Last Updated: December 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
quetiapine
social anxiety disorder
antipsychotic
pilot study

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014