Recruiting

Observational Study

Sponsor:

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

Code:

NCT01391221

Conditions

Major Depression

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Not accepted

Interventions

Duloxetine

Study Details

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

Study ID

NCT01391221

Start date

Jul, 2011

Status verified date

Jul, 2011

Completion date

Aug, 2013

Anticipated

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Duloxetine treatment

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

Interventions

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

Primary outcome measure

  • Cognitive function measured by CANTAB [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Louise Normandeau, Nursing

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

Souad Lhalafi, Nursing

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

Locations

Centre de Recherche Fernand Seguin

Recruiting

Montreal, Quebec, Canada, H1N3V2

Contacts

Louise Normandeau, nursing

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

Souad Lhalafi, nursing

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

Principal Investigator:

Valerie S Tourjman, MD

More Information

Sponsor

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

Last update posted

Jul 19, 2012

Last verified

Jul, 2011

Keywords

  • Depression
  • Inflammation
  • Cognition
  • Pain
  • Allostatic load

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal on 2012-07-19.