Comparing Paroxetine and Duloxetine on Cardiovascular Measures
Phase 2
Completed
- Conditions
- Depressive Symptoms
- Registration Number
- NCT00136383
- Lead Sponsor
- Duke University
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method R-R interval change with deep breathing Respiratory sinus arrhythmia
- Secondary Outcome Measures
Name Time Method Norepinephrine receptor occupancy Montgomery-Asberg Depression Rating Scale (MADRS) Connor-Davidson Resilience Scale Serotonin receptor occupancy Hospital Anxiety and Depression Scale Spielberger State-Trait Anxiety Inventory
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States