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NCT00136383 Clinical Trial

Comparing Paroxetine and Duloxetine on Cardiovascular Measures

Depressive Symptoms Clinical Trial

Official title:
A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00136383
Other study ID # Pro00007207
Secondary ID 6956-05-3R0
Status Completed
Phase Phase 2/Phase 3
First received August 25, 2005
Last updated July 18, 2014
Start date March 2005
Est. completion date June 2007

Study information
Verified date September 2007
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• paroxetine versus duloxetine

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary R-R interval change with deep breathing
Primary Respiratory sinus arrhythmia
Secondary Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary Hospital Anxiety and Depression Scale
Secondary Spielberger State-Trait Anxiety Inventory
Secondary Connor-Davidson Resilience Scale
Secondary Norepinephrine receptor occupancy
Secondary Serotonin receptor occupancy
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