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Comparing Paroxetine and Duloxetine on Cardiovascular Measures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136383
First Posted: August 29, 2005
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
Duke University
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00136383     History of Changes
Other Study ID Numbers: Pro00007207
6956-05-3R0 ( Other Identifier: DUMC )
First Submitted: August 25, 2005
First Posted: August 29, 2005
Last Update Posted: July 21, 2014
Last Verified: September 2007

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Duloxetine Hydrochloride
Paroxetine
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
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