ClinicalTrials.gg
Status unknownNCT01391221Updated Jul 19, 2012

Inflammatory Markers and Cognitive Function in Major Depression

A Phase 4 interventional study of Duloxetine in Major Depression, sponsored by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal. Status unknown at 2 sites in Canada. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-07-19.

Sponsored by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal · Phase 4, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depression

Keywords

  • Depression
  • Inflammation
  • Cognition
  • Pain
  • Allostatic load
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 20 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Duloxetine treatment

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

    Drug: Duloxetine

Interventions

  • 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

    Also known as: Cymbalta

06

What researchers measure

Primary outcomes

  1. Cognitive function measured by CANTAB

    Correlation between cytokines and cognitive function

    Time frame: 12 weeks

Secondary outcomes

  1. pain inhibition

    Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus

    Time frame: 12 weeks

  2. Allostatic load

    Correlation between depressive symptoms, antidepressant treatment status and allostatic load

    Time frame: 12 weeks

07

Study locations

1 of 2 sites recruiting
  • Centre de Recherche Fernand Seguin
    Montreal, Quebec H1N3V2, Canada
    Recruiting
    • Louise Normandeau, nursing · Contacturb.crfs@ssss.gouv.qc.ca · 514-251-4000
    • Souad Lhalafi, nursing · Contacturb.crfs@ssss.gouv.qc.ca · 514-251-4000
    • Valerie S Tourjman, MD · Principal investigator
    • Edouard Kouassi, PharmD · Sub investigator
    • Stephane Potvin, PhD · Sub investigator
    • Pierrich Pusquellech, PhD · Sub investigator
    • Robert-Paul Juster, MSc · Sub investigator
  • Hôpital Maisonneuve Rosemont
    Montreal, Quebec, Canada
    Not yet recruiting
    • Marie Eve Koue, MSc · Contact
    • Jacques Bernier, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01391221
Lead sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Responsible party
Smadar Valerie Tourjman (MDCM, FRCPc, MSc, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal) — Principal investigator
First posted
Jul 11, 2011
Start date
Jul 2011
Primary completion
Aug 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
Jul 19, 2012

Study contacts

Louise Normandeau, Nursing
Contact
urb.crfs@ssss.gouv.qc.ca
514-251-4000 ext. 3535
Souad Lhalafi, Nursing
Contact
urb.crfs@ssss.gouv.qc.ca
514-251-4000 ext. 3416

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Duloxetine

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