Nefazodone in the Treatment of Social Phobia | NCT00231348

Studies
Nefazodone in the Treatment of Social Phobia

NCT00231348

Sponsor

Emory University

Status

Completed

Last Update Posted

Nov 13, 2013Estimated

Enrollment

Phase

Phase 4

Conditions

Social Anxiety Disorder (SAD)

Interventions

Nefazodone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Apr 2000Actual

First Submitted Date

Oct 3, 2005

First Submission Date that Met QC Criteria

Oct 3, 2005

First Posted Date

Oct 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2013

Last Update Posted Date

Nov 13, 2013Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Nefazodone	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Depatment of Psychiatry and Behavioral Sciences		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D000072861	Phobia, Social

Ancestor Terms

ID	Term
D010698	Phobic Disorders
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided