An Open Label, Double-Blind Discontinuation Study of Quetiapine XR in Social Anxiety Disorder - Full Text View

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00606541

Purpose

Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.

Condition	Intervention	Phase
Social Anxiety Disorder	Drug: Quetiapine XR Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	An Open Label, Double-Blind Discontinuation Study of Quetiapine XR in Social Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Kaplan Meier survival of CGI-I [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of CGI-I, BSPS, SPIN [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Quetiapine XR 50mg-400mg per day	Drug: Quetiapine XR This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).
2: Placebo Comparator Placebo	Drug: Placebo Placebo

Arms

Assigned Interventions

1: Experimental

Quetiapine XR 50mg-400mg per day

Drug: Quetiapine XR

This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).

2: Placebo Comparator

Placebo

Drug: Placebo

Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults 18-65 years of age
A primary diagnosis of SAD, using DSM-IV criteria
Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
Written informed consent
A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental 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 within 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
Subjects needing concurrent use of psychotropic medications
History of hypersensitivity to quetiapine
History of cataracts.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606541

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Nabila Lateef 919-684-9701
Principal Investigator: Wie Zhang, MD

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Wei Zhang, MD

Duke University

More Information

No publications provided

Responsible Party:	DUMC ( Wei Zhang /Director of Anxiety and PTSD program )
Study ID Numbers:	IRUSQUET0452, eIRB2146
Study First Received:	January 22, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00606541 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Social Anxiety Disorder
Quetiapine XR
Prevention
tolerability

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Phobic Disorders
Antipsychotic Agents

Pharmacologic Actions
Quetiapine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010