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)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00606541
First received: January 22, 2008
Last updated: July 31, 2014
Last verified: December 2012
  Purpose

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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

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
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 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
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00606541     History of Changes
Other Study ID Numbers: Pro00002146, eIRB2146, IRUSQUET0452
Study First Received: January 22, 2008
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Social Anxiety Disorder
Quetiapine XR
Prevention
tolerability

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Disease
Mental Disorders
Pathologic Processes
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 September 22, 2014