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Completed

NCT Number: NCT00136383

Comparing Paroxetine and Duloxetine on Cardiovascular Measures

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine versus duloxetine

Drug

Primary outcomes

  1. R-R interval change with deep breathing

  2. Respiratory sinus arrhythmia

Secondary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

  2. Hospital Anxiety and Depression Scale

  3. Spielberger State-Trait Anxiety Inventory

  4. Connor-Davidson Resilience Scale

  5. Norepinephrine receptor occupancy

  6. Serotonin receptor occupancy

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Aug 29, 2005
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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