Nefazodone in the Treatment of Social Phobia - Tabular View

Tracking Information

First Received Date ^ICMJE

October 3, 2005

Last Updated Date

October 3, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Social Anxiety Disorder (SAD)

Intervention ^ICMJE

Drug: Nefazodone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

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 ID ^ICMJE

NCT00231348

Responsible Party

Study ID Numbers ^ICMJE

707-97

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