NCT00215228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Jul 2005

Typical duration for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 21, 2014

Status Verified

September 1, 2007

First QC Date

September 20, 2005

Last Update Submit

July 18, 2014

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Effect of treatment on heart rate variability

Secondary Outcomes (2)

  • Effect of treatment on affective variables (depression, anxiety, stress reactivity)

  • Effect of treatment on neurotransmitter transporter occupancy

Interventions

duloxetine vs. escitalopramDRUG

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Wei Zhang, M.D., Ph. D

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Study Completion

August 1, 2007

Last Updated

July 21, 2014

Record last verified: 2007-09

Locations

US(1)