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Inflammatory Markers and Cognitive Function in Major Depression

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ClinicalTrials.gov Identifier: NCT01391221
Recruitment Status : Unknown
Verified July 2011 by Smadar Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine.
Recruitment status was:  Recruiting
First Posted : July 11, 2011
Last Update Posted : July 19, 2012
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Smadar Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Duloxetine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study
Study Start Date : July 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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 Name: Cymbalta




Primary Outcome Measures :
  1. Cognitive function measured by CANTAB [ Time Frame: 12 weeks ]
    Correlation between cytokines and cognitive function


Secondary Outcome Measures :
  1. pain inhibition [ Time Frame: 12 weeks ]
    Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus

  2. Allostatic load [ Time Frame: 12 weeks ]
    Correlation between depressive symptoms, antidepressant treatment status and allostatic load



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391221


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

Locations
Canada, Quebec
Centre de Recherche Fernand Seguin Recruiting
Montreal, Quebec, Canada, H1N3V2
Contact: Louise Normandeau, nursing    514-251-4000 ext 3535    urb.crfs@ssss.gouv.qc.ca   
Contact: Souad Lhalafi, nursing    514-251-4000 ext 3416    urb.crfs@ssss.gouv.qc.ca   
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         
Hôpital Maisonneuve Rosemont Not yet recruiting
Montreal, Quebec, Canada
Contact: Marie Eve Koue, MSc         
Principal Investigator: Jacques Bernier, MD         
Sponsors and Collaborators
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Eli Lilly and Company

Responsible Party: Smadar Valerie Tourjman, MDCM, FRCPc, MSc, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
ClinicalTrials.gov Identifier: NCT01391221     History of Changes
Other Study ID Numbers: 2011005
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: July 2011

Keywords provided by Smadar Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine:
Depression
Inflammation
Cognition
Pain
Allostatic load

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents