Comparing Paroxetine and Duloxetine on Cardiovascular Measures

Duke University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Symptoms

Interventions

paroxetine versus duloxetineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

R-R interval change with deep breathing

Respiratory sinus arrhythmia

Secondary Outcomes

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

Data from ClinicalTrials.gov

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