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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 24
Study Completion Date: April 2000
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Emory University
ClinicalTrials.gov Identifier: NCT00231348     History of Changes
Other Study ID Numbers: 0707-1997
Study First Received: October 3, 2005
Last Updated: November 8, 2013
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:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Nefazodone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014