An Open Label, Double-Blind Discontinuation Study of Quetiapine XR in Social Anxiety Disorder
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Anxiety Disorder
Intervention: Quetiapine XR (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Wei Zhang, MD, Principal Investigator, Affiliation: Duke University
Summary
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.
Clinical Details
Official title: An Open Label, Double-Blind Discontinuation Study of Quetiapine XR in Social Anxiety Disorder
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Kaplan Meier survival of CGI-I
Secondary outcome: Percentage of CGI-I, BSPS, SPIN
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Nabila Lateef, Phone: 919-684-9701
Wie Zhang, MD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: December 2011
Last updated: August 13, 2008
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