Nefazodone in the Treatment of Social Phobia

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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