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Comparing Paroxetine and Duloxetine on Cardiovascular Measures

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ClinicalTrials.gov Identifier: NCT00136383
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 21, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Duke University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Symptoms Drug: paroxetine versus duloxetine Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : March 2005
Actual Study Completion Date : June 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. R-R interval change with deep breathing
  2. Respiratory sinus arrhythmia

Secondary Outcome Measures :
  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

Eligibility Criteria
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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
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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
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
GlaxoSmithKline
Investigators
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Principal Investigator: Wei Zhang, M.D., Ph.D. Duke University
More Information
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ClinicalTrials.gov Identifier: NCT00136383    
Other Study ID Numbers: Pro00007207
6956-05-3R0 ( Other Identifier: DUMC )
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: September 2007
Additional relevant MeSH terms:
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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