Not Signed In -
Paroxetine |
Paxil; Paxil CR |
Clinical Trial: Comparing Paroxetine and Duloxetine on Cardiovascular Measures
This study is currently recruiting patients.
Verified by Davidson, Jonathan R.T., M.D. August 2005
|
Purpose
This double-blind placebo-controlled trial is designed to test to compare the cardiovascular profile of paroxetine CR with duloxetine in outpatients with depressive symptoms.
| Condition | Intervention | Phase |
|---|---|---|
| Depressive Symptoms | Drug: paroxetine vs. duloxetine | Phase II Phase III |
MedlinePlus related topics: Depression
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Study of the Effects of Paroxetine Vs. Duloxetine on Heart Rate VAriability and Autonomic Cardiovascular Control
Further Study Details:
Primary Outcomes: R-R inteval change with deep breathing; Respiratory sinus arrhythmia
Secondary Outcomes: 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
Expected Total Enrollment: 40
Secondary Outcomes: 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
Expected Total Enrollment: 40
Study start: March 2005
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
Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00136383
Nabila Danish 919 684 9701
North Carolina
Duke University Medical Center, Durham, North Carolina, 27705, United States; Recruiting
Study chairs or principal investigators
Jonathan Davidson, M.D., Principal Investigator, Duke University
More Information
Study ID Numbers: 6956-05-3R0
Last Updated: August 26, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00136383
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 26, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00136383
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Resources
- Paroxetine (Drug Digest)
- Paxil (Drug Digest)
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