Official Title: “An Open Label, Double-Blind Discontinuation Study of Quetiapine XR in Social Anxiety Disorder”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

• 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).
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Quetiapine XR 50mg-400mg per day
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Kaplan Meier survival of CGI-I
  • Time Frame: 20 weeks
    Safety Issue?: Yes

Secondary Measures

• Percentage of CGI-I, BSPS, SPIN
  • Time Frame: 20 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duke University

Overall Clinical Trial Officials and Contacts

Wei Zhang, MD Principal Investigator Duke University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00606541

Study ID Number: IRUSQUET0452

ClinicalTrials.gov Identifier: NCT00606541

Health Authority: United States: Institutional Review Board