Nefazodone in the Treatment of Social Phobia

This study has been completed.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by:

Emory University

ClinicalTrials.gov Identifier:

NCT00231348

First received: October 3, 2005

Last updated: NA

Last verified: October 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 3, 2005

Last Updated Date

October 3, 2005

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nefazodone in the Treatment of Social Phobia

Official Title ^ICMJE

Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Social Anxiety Disorder (SAD)

Intervention ^ICMJE

Drug: Nefazodone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00231348

Other Study ID Numbers ^ICMJE

707-97

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

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

Information Provided By

Emory University

Verification Date

October 2005

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

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