Major Depressive DisorderNCT00209066
Treatment of Reduced Heart Rate Variability Associated With Major Depression With Electroconvulsive Therapy
An observational study of Major Depressive Disorder, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Apr 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with major depressive disorder presenting for a course of electroconvulsive therapy.
Who may be able to join
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: A Means to Enhanced Cardiovascular Outcomes: Reduction of Exaggerated Platelet Activity Through Treatment of Depression.
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:
- Heart rate variability (HRV) will be decreased prior to treatment of depression in comparison to post-treatment measures of HRV.
- After 8 treatments with ECT, HRV will be increased under basal conditions.
Read the detailed description
There is considerable evidence that patients with ischemic heart disease (IHD) and concurrent major depression have a less favorable prognosis than patients with IHD alone. Indeed, a number of recent studies implicate major depression in the pathophysiologic progression of cardiovascular disease as an independent risk factor, rather than a reaction to cardiovascular illness. This conclusion is supported by multiple recent studies (Anda et al; 1993; Markowitz and Matthews, 1991; Musselman et al., 1994, 1995).
Increased sympathetic tone and subsequent diminished heart rate variability secondary to elevated circulating levels of catecholamines provides a possible pathophysiologic link between IHD and depression. For example, Carney et al (1988) have established the correlation of increased heart rate and decreased heart rate variability (HRV) in patients with major depression and IHD. Thus it follows that enhancement of sympathetic tone may be important in the independent development of IHD and major depression. The interplay among these systems remains to be investigated. The present study seeks to determine the relationship between major depression and sympathetic tone.
The primary objective of the Research Protocol is to determine the effects of major depressive disorder (MDD) (see Specific Aim 1), and its treatment, on autonomic function (see Specific Aim 2). Twenty-five depressed patients with and 25 depressed patients without a history of ischemic cardiovascular disease will be recruited to this study.
To be determined is whether the exaggerated platelet reactivity and diminished HRV exhibited by depressed patients are affected by treatment with ECT. Autonomic function in depressed patients will be studied longitudinally before and after ECT. Heart rate variability (HRV) in depressed patients who exhibit a therapeutic response to ECT and who exhibited diminished HRV prior to treatment will support the hypothesis that HRV are pathophysiologically associated with the state of major depression. Successful ECT treatment of depressed mood that is not associated with normalization of HRV may indicate that: a) HRV is unrelated to Major Depressive Disorder, or b) HRV may reflect a pre-existing "trait" phenomena of major depressive disorder, or c) directly improve HRV.
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Electroconvulsive Therapy, Platelet Activation
- Medical subject headings
- Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 1998
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- The Dana Foundation
- Responsible party
- Principal investigator, Dominique Musselman, Emory University
- Investigators
- Dominique L Musselman, MD,MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209066
- Sponsor's protocol ID
- 0422-1998
- Other IDs
- 98052113
- Status last verified
- Nov 2013
- First submitted
- 14 Sep 2005
- Last updated
- 19 Nov 2013
- Results posted
- No
Publications
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.
PubMed 22966422
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Means to Enhanced Cardiovascular Outcomes: Reduction of Exaggerated Platelet Activity Through Treatment of Depression.
- ClinicalTrials.gov ID
- NCT00209066
- Acronym / sponsor ID
- 0422-1998
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Electroconvulsive Therapy, Platelet Activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- The Dana Foundation
- Study start
- Nov 1998
- Study completion
- Apr 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Heart rate variability (HRV) will be decreased prior to treatment of depression in comparison to post-treatment measures of HRV.
- After 8 treatments with ECT, HRV will be increased under basal conditions.
Detailed description
There is considerable evidence that patients with ischemic heart disease (IHD) and concurrent major depression have a less favorable prognosis than patients with IHD alone. Indeed, a number of recent studies implicate major depression in the pathophysiologic progression of cardiovascular disease as an independent risk factor, rather than a reaction to cardiovascular illness. This conclusion is supported by multiple recent studies (Anda et al; 1993; Markowitz and Matthews, 1991; Musselman et al., 1994, 1995).
Increased sympathetic tone and subsequent diminished heart rate variability secondary to elevated circulating levels of catecholamines provides a possible pathophysiologic link between IHD and depression. For example, Carney et al (1988) have established the correlation of increased heart rate and decreased heart rate variability (HRV) in patients with major depression and IHD. Thus it follows that enhancement of sympathetic tone may be important in the independent development of IHD and major depression. The interplay among these systems remains to be investigated. The present study seeks to determine the relationship between major depression and sympathetic tone.
The primary objective of the Research Protocol is to determine the effects of major depressive disorder (MDD) (see Specific Aim 1), and its treatment, on autonomic function (see Specific Aim 2). Twenty-five depressed patients with and 25 depressed patients without a history of ischemic cardiovascular disease will be recruited to this study.
To be determined is whether the exaggerated platelet reactivity and diminished HRV exhibited by depressed patients are affected by treatment with ECT. Autonomic function in depressed patients will be studied longitudinally before and after ECT. Heart rate variability (HRV) in depressed patients who exhibit a therapeutic response to ECT and who exhibited diminished HRV prior to treatment will support the hypothesis that HRV are pathophysiologically associated with the state of major depression. Successful ECT treatment of depressed mood that is not associated with normalization of HRV may indicate that: a) HRV is unrelated to Major Depressive Disorder, or b) HRV may reflect a pre-existing "trait" phenomena of major depressive disorder, or c) directly improve HRV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with major depressive disorder presenting for a course of electroconvulsive therapy.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Results publication: PubMed 22966422Royster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique L Musselman, MD,MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00209066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.