Comparing Paroxetine and Duloxetine on Cardiovascular Measures

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

Duke University

ClinicalTrials.gov Identifier:

NCT00136383

First received: August 25, 2005

Last updated: September 18, 2007

Last verified: September 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 25, 2005

Last Updated Date

September 18, 2007

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

R-R interval change with deep breathing
Respiratory sinus arrhythmia

Original Primary Outcome Measures ^ICMJE

R-R inteval change with deep breathing
Respiratory sinus arrhythmia

Change History

Complete list of historical versions of study NCT00136383 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Montgomery-Asberg Depression Rating Scale
Hospital Anxiety and Depression Scale
Spielberger State-Trait Anxiety Inventory
Connor-Davidson Resilience Scale
Norepinephrine receptor occupancy
Serotonin receptor occupancy

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparing Paroxetine and Duloxetine on Cardiovascular Measures

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Depressive Symptoms

Intervention ^ICMJE

Drug: paroxetine versus duloxetine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00136383

Other Study ID Numbers ^ICMJE

6956-05-3R0

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

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

Duke University

Information Provided By

Duke University

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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