Nefazodone in the Treatment of Social Phobia
This study has been completed.
Sponsor:
Emory University
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
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Purpose
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).
| Condition | Intervention | Phase |
|---|---|---|
|
Social Anxiety Disorder (SAD) |
Drug: Nefazodone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates |
Resource links provided by NLM:
Further study details as provided by Emory University:
| Estimated Enrollment: | 24 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231348
Locations
| United States, Georgia | |
| Emory University Depatment of Psychiatry and Behavioral Sciences | |
| Atlanta, Georgia, United States, 30322 | |
Sponsors and Collaborators
Emory University
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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00231348 History of Changes |
| Other Study ID Numbers: | 707-97 |
| Study First Received: | October 3, 2005 |
| Last Updated: | October 3, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emory University:
|
Social anxiety disorder social phobia positron emission tomography (PET |
regional cerebral blood flow (rCBF) nefazodone amygdala |
Additional relevant MeSH terms:
|
Anxiety Disorders Phobic Disorders Mental Disorders Nefazodone Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013