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Inflammatory Markers and Cognitive Function in Major Depression

Primary Purpose

Major Depression

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depression focused on measuring Depression, Inflammation, Cognition, Pain, Allostatic load

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de Recherche Fernand SeguinRecruiting
  • Hôpital Maisonneuve Rosemont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine treatment

Arm Description

Subjects with major depression will be entered into the trial and treated with open label duloxetine

Outcomes

Primary Outcome Measures

Cognitive function measured by CANTAB
Correlation between cytokines and cognitive function

Secondary Outcome Measures

pain inhibition
Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus
Allostatic load
Correlation between depressive symptoms, antidepressant treatment status and allostatic load

Full Information

First Posted
July 7, 2011
Last Updated
July 17, 2012
Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01391221
Brief Title
Inflammatory Markers and Cognitive Function in Major Depression
Official Title
Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Depression, Inflammation, Cognition, Pain, Allostatic load

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine treatment
Arm Type
Experimental
Arm Description
Subjects with major depression will be entered into the trial and treated with open label duloxetine
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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
Primary Outcome Measure Information:
Title
Cognitive function measured by CANTAB
Description
Correlation between cytokines and cognitive function
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
pain inhibition
Description
Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus
Time Frame
12 weeks
Title
Allostatic load
Description
Correlation between depressive symptoms, antidepressant treatment status and allostatic load
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Normandeau, Nursing
Phone
514-251-4000
Ext
3535
Email
urb.crfs@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Souad Lhalafi, Nursing
Phone
514-251-4000
Ext
3416
Email
urb.crfs@ssss.gouv.qc.ca
Facility Information:
Facility Name
Centre de Recherche Fernand Seguin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N3V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Normandeau, nursing
Phone
514-251-4000
Ext
3535
Email
urb.crfs@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Souad Lhalafi, nursing
Phone
514-251-4000
Ext
3416
Email
urb.crfs@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Valerie S Tourjman, MD
First Name & Middle Initial & Last Name & Degree
Edouard Kouassi, PharmD
First Name & Middle Initial & Last Name & Degree
Stephane Potvin, PhD
First Name & Middle Initial & Last Name & Degree
Pierrich Pusquellech, PhD
First Name & Middle Initial & Last Name & Degree
Robert-Paul Juster, MSc
Facility Name
Hôpital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Eve Koue, MSc
First Name & Middle Initial & Last Name & Degree
Jacques Bernier, MD

12. IPD Sharing Statement

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Inflammatory Markers and Cognitive Function in Major Depression

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