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Nefazodone in the Treatment of Social Phobia

NCT ID: NCT00231348

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2000-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Social Anxiety Disorder (SAD)

Keywords

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Social anxiety disorder social phobia positron emission tomography (PET regional cerebral blood flow (rCBF) nefazodone amygdala

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nefazodone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles B Nemeroff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University Department of Psychiatry and Behavioral Sciences

Clinton D Kilts, PhD

Role: STUDY_DIRECTOR

Emory University Department of Psychiatry and Behavioral Sciences

Jeffrey Newport, MD

Role: STUDY_DIRECTOR

Emory University Department of Psychiatry and Behavioral Sciences

Locations

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Emory University Depatment of Psychiatry and Behavioral Sciences

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0707-1997

Identifier Type: -

Identifier Source: org_study_id