Nefazodone in the Treatment of Social Phobia

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

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

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder (SAD)
• Intervention / Treatment: Drug: Nefazodone

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: Interventional
• Enrollment: 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Depatment of Psychiatry and Behavioral Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Completion (Actual): April 1, 2000

Study Registration Dates

• First Submitted: October 3, 2005
• First Submitted That Met QC Criteria: October 3, 2005
• First Posted (Estimate): October 4, 2005

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: amygdala; social phobia; Social anxiety disorder; positron emission tomography (PET; regional cerebral blood flow (rCBF); nefazodone
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Nefazodone
• Other Study ID Numbers: 0707-1997