Comparing Paroxetine and Duloxetine on Cardiovascular Mea... | NCT00136383

Studies
Comparing Paroxetine and Duloxetine on Cardiovascular Measures

NCT00136383

Sponsor

Duke University

Status

Completed

Last Update Posted

Jul 21, 2014Estimated

Enrollment

40Estimated

Phase

Phase 2Phase 3

Conditions

Depressive Symptoms

Interventions

paroxetine versus duloxetine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
6956-05-3R0	Other Identifier	DUMC

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2014

Last Update Posted Date

Jul 21, 2014Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
paroxetine versus duloxetine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
R-R interval change with deep breathing
Respiratory sinus arrhythmia

Secondary Outcomes

Measure	Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Hospital Anxiety and Depression Scale
Spielberger State-Trait Anxiety Inventory

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Zhang, M.D., Ph.D.	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27705	United States

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior