Major Depressive Disorder Clinical Trial
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:
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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