NCT00136383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 21, 2014

Status Verified

September 1, 2007

First QC Date

August 25, 2005

Last Update Submit

July 18, 2014

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (2)

  • R-R interval change with deep breathing

  • Respiratory sinus arrhythmia

Secondary Outcomes (6)

  • Montgomery-Asberg Depression Rating Scale (MADRS)

  • Hospital Anxiety and Depression Scale

  • Spielberger State-Trait Anxiety Inventory

  • Connor-Davidson Resilience Scale

  • Norepinephrine receptor occupancy

  • +1 more secondary outcomes

Interventions

paroxetine versus duloxetineDRUG

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Depressive symptoms
  • Ages 20-60
  • In good medical health and not pregnant

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Wei Zhang, M.D., Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

March 1, 2005

Study Completion

June 1, 2007

Last Updated

July 21, 2014

Record last verified: 2007-09

Locations

US(1)