Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215228
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2005-09-20
Brief Title:
Effects of Duloxetine vs Escitalopram on Heart Rate Variability in Depression
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Effects of Escitalopram vs Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control
Status:
COMPLETED
Status Verified Date:
2007-09
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:
Low heart rate variability is a marker of increased risk of cardiac mortality and is observed in depressed coronary artery disease patients Some antidepressants may themselves however decrease heart rate variability We will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine which has noradrenergic activity than escitalopram a selective serotonin reuptake inhibitor We will also test the hypothesis that changes in heart rate variability are related to the magnitude of norepinephrine transporter occupancy
Detailed Description:
Evaluation of heart rate variability HRV has been shown to be a valuable tool for measuring autonomic dysfunction associated with depression and with cardiac disease Low HRV is a marker of increased risk of cardiac mortality and is observed in depressed coronary artery disease patients and in anxious patients post-MI Treatment with sympathomimetic antidepressants such as MAO inhibitors and tricyclics reduce HRV further and have been associated with elevated heart rate orthostatic hypotension and with adverse cardiac events Although there is increasing evidence that the selective serotonin reuptake inhibitor SSRI class of antidepressants have minimal effects on the cardiovascular system the case is less clear with the SNRI antidepressants which block the reuptake of both serotonin and norepinephrine It is possible that measures of the extent of norepinephrine transporter blockade or inhibition may relate to the HRV reduction seen with noradrenergic drugs Given these considerations we propose a study to compare the cardiovascular profile of the SSRI escitalopram Lexapro with the most recently available SNRI duloxetine in outpatients with depression Using HRV methodology we will test the hypothesis that greater reduction in HRV will be associated with duloxetine than escitalopram In addition we will measure the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug This will allow us to examine the relationship between changes in HRV to the magnitude of transporter inhibiting effects of each drug
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 |
|---|---|---|---|
| 6957-05-3R0 | OTHER | DUMC | None |