Effects of Duloxetine vs. Escitalopram on Heart Rate Variability in Depression

Major Depressive Disorder Clinical Trial

Official title:

Effects of Escitalopram vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215228
• Other study ID #: Pro00007159
• Secondary ID: 6957-05-3R0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 20, 2005
• Last updated: July 18, 2014
• Start date: July 2005
• Est. completion date: August 2007

Study information

• Verified date: September 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• adults 20-60 years of age

• a primary diagnosis of depression using DSM-IV criteria

• written informed consent

• a negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

• history of cardiovascular disease

• history of hypertension

• history of bipolar disorder

• history of schizophrenia or other psychotic disorder

• alcohol or other substance abuse within the last 3 months

• history of cognitive impairment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• duloxetine vs. escitalopram

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of treatment on heart rate variability
Secondary	Effect of treatment on affective variables (depression, anxiety, stress reactivity)
Secondary	Effect of treatment on neurotransmitter transporter occupancy