NCT00231348

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

First QC Date

October 3, 2005

Last Update Submit

November 8, 2013

Conditions

Social Anxiety Disorder (SAD)

Keywords

Social anxiety disordersocial phobiapositron emission tomography (PETregional cerebral blood flow (rCBF)nefazodoneamygdala

Interventions

NefazodoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Depatment of Psychiatry and Behavioral Sciences

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

nefazodone

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Charles B Nemeroff, MD, PhD

    Emory University Department of Psychiatry and Behavioral Sciences

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Completion

April 1, 2000

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

US(1)