Inflammatory Markers and Cognitive Function in Major Depression

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391221

Enrollment

Registered

2011-07-11

Start date

2011-07-31

Completion date

2013-08-31

Last updated

2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

Depression, Inflammation, Cognition, Pain, Allostatic load

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.

Interventions

DRUGDuloxetine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cognitive function measured by CANTAB	12 weeks	Correlation between cytokines and cognitive function

Secondary

Measure	Time frame	Description
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

Countries

Canada

Contacts

Primary ContactLouise Normandeau, Nursing

urb.crfs@ssss.gouv.qc.ca514-251-4000

Backup ContactSouad Lhalafi, Nursing