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

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.

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 Investigator: Duke University Other

Overall Clinical Trial Officials and Contacts

Wei Zhang, MD Principal Investigator Duke University  

Information obtained from ClinicalTrials.gov on February 12, 2012

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