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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide; Duloxetine Hydrochloride

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