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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01391221
Other study ID # 2011005
Secondary ID
Status Recruiting
Phase Phase 4
First received July 7, 2011
Last updated July 17, 2012
Start date July 2011
Est. completion date August 2013

Study information

Verified date July 2011
Source Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Contact Louise Normandeau, Nursing
Phone 514-251-4000
Email urb.crfs@ssss.gouv.qc.ca
Is FDA regulated No
Health authority Canada:Santé Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
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

Locations

Country Name City State
Canada Centre de Recherche Fernand Seguin Montreal Quebec
Canada Hôpital Maisonneuve Rosemont Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive function measured by CANTAB Correlation between cytokines and cognitive function 12 weeks No
Secondary pain inhibition Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus 12 weeks No
Secondary Allostatic load Correlation between depressive symptoms, antidepressant treatment status and allostatic load 12 weeks No
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