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Nefazodone in the Treatment of Social Phobia

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Emory University
ClinicalTrials.gov Identifier:
NCT00231348
First received: October 3, 2005
Last updated: November 8, 2013
Last verified: November 2013

October 3, 2005
November 8, 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231348
0707-1997
Not Provided
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