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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215228
First Posted: September 22, 2005
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University
  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
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

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215228     History of Changes
Other Study ID Numbers: Pro00007159
6957-05-3R0 ( Other Identifier: DUMC )
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: July 21, 2014
Last Verified: September 2007

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Duloxetine Hydrochloride
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Sensory System Agents