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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00215228
First received: September 20, 2005
Last updated: July 18, 2014
Last verified: September 2007

September 20, 2005
July 18, 2014
July 2005
Not Provided
Effect of treatment on heart rate variability
Same as current
Complete list of historical versions of study NCT00215228 on ClinicalTrials.gov Archive Site
  • Effect of treatment on affective variables (depression, anxiety, stress reactivity)
  • Effect of treatment on neurotransmitter transporter occupancy
Same as current
Not Provided
Not Provided
 
Effects of Duloxetine vs. Escitalopram on Heart Rate Variability in Depression
Effects of Escitalopram vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Major Depressive Disorder
Drug: duloxetine vs. escitalopram
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2007
Not Provided

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215228
Pro00007159, 6957-05-3R0
Not Provided
Duke University
Duke University
Forest Laboratories
Principal Investigator: Wei Zhang, M.D., Ph. D Duke University
Duke University
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP