Inflammatory Markers and Cognitive Function in Major Depression

Phase 4

• Conditions: Major Depression
• Interventions: Drug: Duloxetine

• Registration Number: NCT01391221
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-19
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duloxetine treatment	Duloxetine	Subjects with major depression will be entered into the trial and treated with open label duloxetine

Primary Outcome Measures

Name	Time	Method
Cognitive function measured by CANTAB	12 weeks	Correlation between cytokines and cognitive function

Secondary Outcome Measures

Name	Time	Method
pain inhibition	12 weeks	Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus
Allostatic load	12 weeks	Correlation between depressive symptoms, antidepressant treatment status and allostatic load

Trial Locations

Locations (2)

Centre de Recherche Fernand Seguin; 🇨🇦 Montreal, Quebec, Canada

Hôpital Maisonneuve Rosemont; 🇨🇦 Montreal, Quebec, Canada