NCT00209066

Completed

Treatment of Reduced Heart Rate Variability Associated With ...

Emory University Source

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Other study identifiers

Sponsor study identifier

0422-1998

Secondary identifiers

98052113

OTHER · Other

Study Type

observational

Estimated enrollment

50

Locations

1 country

Sites

1

Timeline

Study Start

November 1998

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The purpose of this study is to evaluate alterations in sympathetic tone in patients with major depression with and without ischemic heart disease and then to reevaluate these patients after 8 treatments with electroconvulsive therapy(ECT). We expect to support the hypothesis that HRV are pathophysiologically associated with the state of major depression. We hypothesize the following:

1.Heart rate variability (HRV) will be decreased prior to treatment of depression in comparison to post-treatment measures of HRV.
2.After 8 treatments with ECT, HRV will be increased under basal conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 50 participants
Study completion date: April 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 1998
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
April 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 14, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)

Last Updated: November 19, 2013
Status Verified: November 2013
Last Update Submitted: November 17, 2013

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisorderElectroconvulsive TherapyPlatelet Activation

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with major depressive disorder presenting for a course of electroconvulsive therapy.

You may not qualify if:

Patients will not be accepted into the study if they abuse alcohol or drugs.
Patients will be excluded from the study if they have had an MI within the past three months, unstable crescendo angina or ongoing warfarin treatment
Patients also will not be accepted into the study if ECT will be harmful to them. These patients include:
those who have had a recent MI (\<3 months)
those who have an infection of the brain,

Sponsors & Collaborators

Emory University
Otherlead
The Dana Foundation
Othercollaborator

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Related Publications (1)

Royster EB, Trimble LM, Cotsonis G, Schmotzer B, Manatunga A, Rushing NN, Pagnoni G, Auyeung SF, Brown AR, Schoenbeck J, Murthy S, McDonald WM, Musselman DL. Changes in heart rate variability of depressed patients after electroconvulsive therapy. Cardiovasc Psychiatry Neurol. 2012;2012:794043. doi: 10.1155/2012/794043. Epub 2012 Aug 27.
PMID: 22966422RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

Dominique L Musselman, MD,MS
Emory University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

November 1998

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 2005

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NCT00367341

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NCT01260649

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those who have a condition in which there is increased intracranial pressure (e.g. a brain tumor)

those who cannot tolerate general anesthesia.

Any patient with a current DSM-IV Axis I diagnosis other than major depression will be excluded from the study.

Contact the study team to confirm eligibility.

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

November 19, 2013

Record last verified: 2013-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00209066
Data provider: ClinicalTrials.gov
Source updated: 2013-11-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:04 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations