Status:
COMPLETED
Comparing Paroxetine and Duloxetine on Cardiovascular Measures
Lead Sponsor:
Duke University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Depressive Symptoms
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
PHASE3
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.
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 depres...
Eligibility Criteria
Inclusion
- Depressive symptoms
- Ages 20-60
- In good medical health and not pregnant
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00136383
Start Date
March 1 2005
End Date
June 1 2007
Last Update
July 21 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705