The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD)...
Date First Received: October 3, 2005
Last Updated: October 3, 2005
Verified by: Emory University, October 2005
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Completed
Estimated Enrollment: 24
Brief Summary
Official Title: “Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Detailed Clinical Trial Description
The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes in cerebral blood flow were correlated with self-rated anxiety measures.
Intervention(s) in this Clinical Trial
- Drug: Nefazodone
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65
Exclusion Criteria:
- A history of bipolar disorder, psychotic illness, or any other anxiety disorders, organic brain disease or active drug or alcohol abuse within one year as assessed by the SCID-P and interview, or a concurrent medical condition that would not be compatible with the study in the opinion of the principal investigator. Patients required to be free of psychotropic or beta-blocker medication for 2 weeks prior to study. Pts taking fluoxetine required to be drug-free for 6 weeks.
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?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Emory University
Overall Clinical Trial Officials and Contacts
Charles B Nemeroff, MD, PhD Principal Investigator Emory University Department of Psychiatry and Behavioral Sciences
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00231348
Study ID Number: 707-97
ClinicalTrials.gov Identifier: NCT00231348
Health Authority: United States: Food and Drug Administration
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