Quetiapine in Social Anxiety Disorder - Full Text View

Sponsor:	Duke University
Collaborator:	AstraZeneca
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00215254

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 II Phase III

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:

MedlinePlus related topics: Anxiety Phobias

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

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

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
Phobic Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012