Comparing Paroxetine and Duloxetine on Cardiovascular Measures

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00136383
First received: August 25, 2005
Last updated: July 18, 2014
Last verified: September 2007
  Purpose

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136383

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
GlaxoSmithKline
Investigators
Principal Investigator: Wei Zhang, M.D., Ph.D. Duke University
  More Information

No publications provided

ClinicalTrials.gov 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:
Depression
Behavioral Symptoms
Paroxetine
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on July 28, 2014