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NCT00215228 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target

NCT00215228: Completed Phase 2 study, sponsored by Duke University.

NCT00215228 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00215228, a Phase 2 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target

Study 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.

Interventions

  • DRUG duloxetine vs. escitalopram

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2005-07
Est. Completion 2007-08
Phase Phase 2
Duke University

1,725 total trials

What the finished NCT00215228 record still lists

NCT00215228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which duloxetine vs. escitalopram is the first listed.

NCT00215228 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00215228 about?

NCT00215228 is a clinical study titled "Effects of Duloxetine vs. Escitalopram on Heart Rate Variability in Depression". 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 wi...

What is the current status of trial NCT00215228?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2005-07. Estimated completion is 2007-08.

What interventions are being tested in trial NCT00215228?

The interventions under investigation include: duloxetine vs. escitalopram (DRUG).

Who is sponsoring clinical trial NCT00215228?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00215228's enrollment target sits among peer trials

26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00215228, the US trial registry maintained by the National Library of Medicine. NCT00215228 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.