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Nefazodone in the Treatment of Social Phobia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231348
First Posted: October 4, 2005
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Emory University
October 3, 2005
October 4, 2005
November 13, 2013
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Complete list of historical versions of study NCT00231348 on ClinicalTrials.gov Archive Site
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Nefazodone in the Treatment of Social Phobia
Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).
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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Social Anxiety Disorder (SAD)
Drug: Nefazodone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2000
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00231348
0707-1997
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Emory University
Emory University
Bristol-Myers Squibb
Principal Investigator: Charles B Nemeroff, MD, PhD Emory University Department of Psychiatry and Behavioral Sciences
Study Director: Clinton D Kilts, PhD Emory University Department of Psychiatry and Behavioral Sciences
Study Director: Jeffrey Newport, MD Emory University Department of Psychiatry and Behavioral Sciences
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP