Inflammatory Markers and Cognitive Function in Major Depression

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Status and phase: Unknown; Phase 4

Conditions: Major Depression

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01391221

2011005

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Duloxetine treatment

Experimental group

Description:

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

Treatment:

Drug: Duloxetine