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Nefazodone in the Treatment of Social Phobia

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ClinicalTrials.gov Identifier: NCT00231348
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Emory University

Brief Summary:
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder (SAD) Drug: Nefazodone Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates
Actual Study Completion Date : April 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231348


Locations
United States, Georgia
Emory University Depatment of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Bristol-Myers Squibb
Investigators
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

Responsible Party: Emory University
ClinicalTrials.gov Identifier: NCT00231348     History of Changes
Other Study ID Numbers: 0707-1997
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Emory University:
Social anxiety disorder
social phobia
positron emission tomography (PET
regional cerebral blood flow (rCBF)
nefazodone
amygdala

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Nefazodone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs