Nefazodone in the Treatment of Social Phobia

Social Anxiety Disorder (SAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231348
• Other study ID #: 0707-1997
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2005
• Last updated: November 8, 2013
• Est. completion date: April 2000

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder (SAD)

Intervention

Drug:
• Nefazodone

Locations

Country	Name	City	State
United States	Emory University Depatment of Psychiatry and Behavioral Sciences	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States,