Comparing Paroxetine and Duloxetine on Cardiovascular Measures

Duke University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Depressive Symptoms

Treatments

Drug: paroxetine versus duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00136383

Pro00007207

6956-05-3R0 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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