Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209066
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2005-09-14
Brief Title:
Treatment of Reduced Heart Rate Variability Associated With Major Depression With Electroconvulsive Therapy
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Means to Enhanced Cardiovascular Outcomes Reduction of Exaggerated Platelet Activity Through Treatment of Depression
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 therapyECT 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98052113 | OTHER | Other | None |