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

This study has been terminated.
(The study was terminated by the sponsor due to budgetary issues)
Information provided by (Responsible Party):
Duke University Identifier:
First received: January 22, 2008
Last updated: July 31, 2014
Last verified: December 2012
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 Intervention Phase
Social Anxiety Disorder Drug: Quetiapine XR Drug: Placebo Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Duke University:

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

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

Enrollment: 55
Study Start Date: January 2008
Study Completion Date: November 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00606541

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Wei Zhang, MD Duke University
  More Information

Responsible Party: Duke University Identifier: NCT00606541     History of Changes
Other Study ID Numbers: Pro00002146
Study First Received: January 22, 2008
Last Updated: July 31, 2014

Keywords provided by Duke University:
Social Anxiety Disorder
Quetiapine XR

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 17, 2017