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Clinical Trials/NCT01391221
NCT01391221
Unknown
Phase 4

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

InterventionsDuloxetine

Overview

Phase
Phase 4
Intervention
Duloxetine
Conditions
Major Depression
Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Enrollment
20
Locations
2
Primary Endpoint
Cognitive function measured by CANTAB
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
August 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Smadar Valerie Tourjman

MDCM, FRCPc, MSc

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

Eligibility 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

Arms & Interventions

Duloxetine treatment

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

Intervention: Duloxetine

Outcomes

Primary Outcomes

Cognitive function measured by CANTAB

Time Frame: 12 weeks

Correlation between cytokines and cognitive function

Secondary Outcomes

  • pain inhibition(12 weeks)
  • Allostatic load(12 weeks)

Study Sites (2)

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