Inflammatory Markers and Cognitive Function in Major Depression

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01391221
• Other study ID #: 2011005
• Status: Recruiting
• Phase: Phase 4
• First received: July 7, 2011
• Last updated: July 17, 2012
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2011
• Source: Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
• Contact: Louise Normandeau, Nursing
• Phone: 514-251-4000
• Email: urb.crfs[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Health authority: Canada:Santé Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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

Locations

Country	Name	City	State
Canada	Centre de Recherche Fernand Seguin	Montreal	Quebec
Canada	Hôpital Maisonneuve Rosemont	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function measured by CANTAB	Correlation between cytokines and cognitive function	12 weeks	No
Secondary	pain inhibition	Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus	12 weeks	No
Secondary	Allostatic load	Correlation between depressive symptoms, antidepressant treatment status and allostatic load	12 weeks	No