Inflammatory Markers and Cognitive Function in Major Depression

July 17, 2012 updated by: Smadar Valerie Tourjman, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study

Major depression is accompanied by cognitive changes as well as alterations in multiple physical functions. The inflammatory system is altered generally toward a pro-inflammatory state. Antidepressants are associated with a decrease in this proinflammatory state. This study aims to generate pilot data concerning a possible link between cognition, inflammation and response to treatment. The cognitive function of subjects with major depression will be tested before and after treatment with duloxetine. Inflammatory markers will be measured at both time points.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1N3V2
        • Recruiting
        • Centre de Recherche Fernand Seguin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valerie S Tourjman, MD
        • Sub-Investigator:
          • Edouard Kouassi, PharmD
        • Sub-Investigator:
          • Stephane Potvin, PhD
        • Sub-Investigator:
          • Pierrich Pusquellech, PhD
        • Sub-Investigator:
          • Robert-Paul Juster, MSc
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • Hopital Maisonneuve Rosemont
        • Contact:
          • Marie Eve Koue, MSc
        • Principal Investigator:
          • Jacques Bernier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-50 Primary diagnosis of major depression Ability to give informed consent

Exclusion Criteria:

  • Neurologic disorders affecting cognition
  • Unstable or untreated medical disorders
  • Medical disorders associated with pain
  • Recent pregnancy or delivery
  • Psychiatric disorders other than MD which are the primary focus of treatment
  • Treatment with antidepressants in the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duloxetine treatment
Subjects with major depression will be entered into the trial and treated with open label duloxetine
Drug: Duloxetine
Subjects with major depression will be entered into the trial and treated with duloxetine 30 mg for one week, followed by 60 mg for 8 weeks. The option of increasing the dose as clinically indicated to 120mg is possible for the last 4 weeks of the study intervention
Other Names:
  • Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function measured by CANTAB
Time Frame: 12 weeks
Correlation between cytokines and cognitive function
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain inhibition
Time Frame: 12 weeks
Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus
12 weeks
Allostatic load
Time Frame: 12 weeks
Correlation between depressive symptoms, antidepressant treatment status and allostatic load
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Collaborators

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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