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Quetiapine in Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215254
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 19, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: quetiapine Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder
Study Start Date : March 2004
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Quetiapine

Primary Outcome Measures :
  1. Brief Social Phobia Scale (BSPS)

Secondary Outcome Measures :
  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)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215254

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

Layout table for additonal information Identifier: NCT00215254    
Other Study ID Numbers: 5639-04-3R0
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 19, 2006
Last Verified: March 2006
Keywords provided by Duke University:
social anxiety disorder
pilot study
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs