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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: duloxetine vs. escitalopram
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Escitalopram vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Effect of treatment on heart rate variability

Secondary Outcome Measures:
  • Effect of treatment on affective variables (depression, anxiety, stress reactivity)
  • Effect of treatment on neurotransmitter transporter occupancy

Estimated Enrollment: 26
Study Start Date: July 2005
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00215228

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Forest Laboratories
Investigators
Principal Investigator: Wei Zhang, M.D., Ph. D Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215228     History of Changes
Other Study ID Numbers: Pro00007159, 6957-05-3R0
Study First Received: September 20, 2005
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014