Comparing Paroxetine and Duloxetine on Cardiovascular Measures

July 18, 2014 updated by: Duke University

A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Depressive symptoms
  • Ages 20-60
  • In good medical health and not pregnant

Exclusion Criteria:

  • Bipolar disorder
  • Schizophrenia or other psychotic disorder
  • Alcohol or other substance abuse within the last 3 months
  • Cognitive impairment
  • History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
R-R interval change with deep breathing
Respiratory sinus arrhythmia

Secondary Outcome Measures

Outcome Measure
Montgomery-Asberg Depression Rating Scale (MADRS)
Hospital Anxiety and Depression Scale
Spielberger State-Trait Anxiety Inventory
Connor-Davidson Resilience Scale
Norepinephrine receptor occupancy
Serotonin receptor occupancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Wei Zhang, M.D., Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00007207
  • 6956-05-3R0 (Other Identifier: DUMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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