Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Comparing Paroxetine and Duloxetine on Cardiovascular Measures

This study has been completed.
Information provided by:
Duke University Identifier:
First received: August 25, 2005
Last updated: July 18, 2014
Last verified: September 2007
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.

Condition Intervention Phase
Depressive Symptoms
Drug: paroxetine versus duloxetine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • R-R interval change with deep breathing
  • Respiratory sinus arrhythmia

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: March 2005
Study Completion Date: June 2007
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.

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00136383

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Wei Zhang, M.D., Ph.D. Duke University
  More Information Identifier: NCT00136383     History of Changes
Other Study ID Numbers: Pro00007207  6956-05-3R0 
Study First Received: August 25, 2005
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on October 20, 2016