Nefazodone in the Treatment of Social Phobia

This study has been completed.

First Received: October 3, 2005 No Changes Posted

Sponsor:	Emory University
Collaborator:	Bristol-Myers Squibb
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00231348

Purpose

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

Condition	Intervention	Phase
Social Anxiety Disorder (SAD)	Drug: Nefazodone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias

Drug Information available for: Nefazodone hydrochloride Nefazodone

U.S. FDA Resources

Further study details as provided by Emory University:

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Study ID Numbers:	707-97
Study First Received:	October 3, 2005
Last Updated:	October 3, 2005
ClinicalTrials.gov Identifier:	NCT00231348 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Nefazodone
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Psychotropic Drugs

Antidepressive Agents, Second-Generation
Phobic Disorders
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009