Comparing Paroxetine and Duloxetine on Cardiovascular Measures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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paroxetine versus duloxetine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No