Inflammatory Markers and Cognitive Function in Major Depression

NCT ID: NCT01391221

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Major Depression

Keywords

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Depression Inflammation Cognition Pain Allostatic load

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Duloxetine treatment

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

Group Type EXPERIMENTAL

Duloxetine

Intervention Type 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

Interventions

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Duloxetine

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

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Smadar Valerie Tourjman

MDCM, FRCPc, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre de Recherche Fernand Seguin

Montreal, Quebec, Canada

Site Status RECRUITING

Hôpital Maisonneuve Rosemont

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Louise Normandeau, Nursing

Role: CONTACT

Phone: 514-251-4000

Email: [email protected]

Souad Lhalafi, Nursing

Role: CONTACT

Phone: 514-251-4000

Email: [email protected]

Facility Contacts

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Louise Normandeau, nursing

Role: primary

Souad Lhalafi, nursing

Role: backup

Marie Eve Koue, MSc

Role: primary

Other Identifiers

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2011005

Identifier Type: -

Identifier Source: org_study_id