Back to resultsNefazodone in the Treatment of Social Phobia
Primary Purpose
Social Anxiety Disorder (SAD)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nefazodone
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder (SAD) focused on measuring Social anxiety disorder, social phobia, positron emission tomography (PET, regional cerebral blood flow (rCBF), nefazodone, amygdala
Eligibility 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.
Sites / Locations
- Emory University Depatment of Psychiatry and Behavioral Sciences
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00231348
First Posted
October 3, 2005
Last Updated
November 8, 2013
Sponsor
Emory University
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00231348
Brief Title
Nefazodone in the Treatment of Social Phobia
Official Title
Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emory University
Collaborators
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder (SAD)
Keywords
Social anxiety disorder, social phobia, positron emission tomography (PET, regional cerebral blood flow (rCBF), nefazodone, amygdala
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nefazodone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles B Nemeroff, MD, PhD
Organizational Affiliation
Emory University Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clinton D Kilts, PhD
Organizational Affiliation
Emory University Department of Psychiatry and Behavioral Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeffrey Newport, MD
Organizational Affiliation
Emory University Department of Psychiatry and Behavioral Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Emory University Depatment of Psychiatry and Behavioral Sciences
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nefazodone in the Treatment of Social Phobia
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