NCT00209066

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 1998

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

First QC Date

September 14, 2005

Last Update Submit

November 17, 2013

Conditions

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,
  • 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.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

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.

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 1, 1998

Study Completion

April 1, 2005

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations