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An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

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: NCT00606541
Recruitment Status : Terminated (The study was terminated by the sponsor due to budgetary issues)
First Posted : February 4, 2008
Last Update Posted : August 1, 2014
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Quetiapine XR Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder
Study Start Date : January 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: 1
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).
Other Name: Seroquel XR

Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Percentage of CGI-I, BSPS, SPIN [ Time Frame: 20 weeks ]

Information from the National Library of Medicine

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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:

  • Adults 18-65 years of age
  • A primary diagnosis of SAD,using Diagnostic Standard Manual IV(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.

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): NCT00606541

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Wei Zhang, MD Duke University
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Responsible Party: Duke University Identifier: NCT00606541    
Other Study ID Numbers: Pro00002146
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: August 1, 2014
Last Verified: December 2012
Keywords provided by Duke University:
Social Anxiety Disorder
Quetiapine XR
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs