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

August 25, 2005
July 18, 2014
March 2005
Not Provided
  • R-R interval change with deep breathing
  • Respiratory sinus arrhythmia
  • R-R inteval change with deep breathing
  • Respiratory sinus arrhythmia
Complete list of historical versions of study NCT00136383 on ClinicalTrials.gov Archive Site
  • 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
  • Montgomery-Asberg Depression Rating Scale
  • Hospital Anxiety and Depression Scale
  • Spielberger State-Trait Anxiety Inventory
  • Connor-Davidson Resilience Scale
  • Norepinephrine receptor occupancy
  • Serotonin receptor occupancy
Not Provided
Not Provided
 
Comparing Paroxetine and Duloxetine on Cardiovascular Measures
A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depressive Symptoms
Drug: paroxetine versus duloxetine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2007
Not Provided

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136383
Pro00007207, 6956-05-3R0
Not Provided
Not Provided
Duke University
GlaxoSmithKline
Principal Investigator: Wei Zhang, M.D., Ph.D. Duke University
Duke University
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP