Inflammatory Markers and Cognitive Function in Major Depression

NCT01391221 | Unknown Phase 4

• 1 other identifier: 2011005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depression

Keywords

Depression; Inflammation; Cognition; Pain; Allostatic load

Outcome Measures

Primary Outcomes (1)

• Cognitive function measured by CANTAB

  Correlation between cytokines and cognitive function

  12 weeks

Secondary Outcomes (2)

• pain inhibition

  12 weeks

• Allostatic load

  12 weeks

Study Arms (1)

Duloxetine treatment

EXPERIMENTAL

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

Drug: Duloxetine

Interventions

Duloxetine DRUG

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

Also known as: Cymbalta

Duloxetine treatment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-50 Primary diagnosis of major depression Ability to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Centre de Recherche Fernand Seguin

Montreal, Quebec, H1N3V2, Canada

RECRUITING

Hôpital Maisonneuve Rosemont

Montreal, Quebec, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Inflammation; Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Louise Normandeau, Nursing

CONTACT

514-251-4000; urb.crfs@ssss.gouv.qc.ca

Souad Lhalafi, Nursing

CONTACT

514-251-4000; urb.crfs@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDCM, FRCPc, MSc

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 19, 2012

Record last verified: 2011-07

Locations

CA (2)