Comparing Paroxetine and Duloxetine on Cardiovascular Measures - Full Text View

Sponsors and Collaborators:	Duke University GlaxoSmithKline
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00136383

Purpose

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.

Condition	Intervention	Phase
Depressive Symptoms	Drug: paroxetine versus duloxetine	Phase II Phase III

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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 as provided by Duke University:

Primary Outcome Measures:

R-R interval change with deep breathing
Respiratory sinus arrhythmia

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	March 2005
Study Completion Date:	June 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136383

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

GlaxoSmithKline

Investigators

Principal Investigator:

Wei Zhang, M.D., Ph.D.

Duke University

More Information

Study ID Numbers:	6956-05-3R0
Study First Received:	August 25, 2005
Last Updated:	September 18, 2007
ClinicalTrials.gov Identifier:	NCT00136383
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine
Depression
Depressive Disorder
Paroxetine

Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009