Major DepressionPhase 4NCT01391221
Inflammatory Markers and Cognitive Function in Major Depression
A Phase 4 study testing Duloxetine in people with Major Depression, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2011to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-50 Primary diagnosis of major depression Ability to give informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Centre de Recherche Fernand Seguin
Montreal, Quebec, H1N3V2
Louise Normandeau, nursing, 514-251-4000 ext. 3535, urb.crfs@ssss.gouv.qc.ca
Souad Lhalafi, nursing, 514-251-4000 ext. 3416, urb.crfs@ssss.gouv.qc.ca
- Not yet recruiting
Hôpital Maisonneuve Rosemont
Montreal, Quebec
Marie Eve Koue, MSc
Jacques Bernier, MD
About this study
Official title: Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study
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
- Being tested
- Duloxetine
- Keywords
- Depression, Inflammation, Cognition, Pain, Allostatic load
- Medical subject headings
- Depressive Disorder, Major, Depression, Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
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 group | Role | What they receive |
|---|---|---|
| Duloxetine treatment | Experimental | Subjects with major depression will be entered into the trial and treated with open label duloxetine Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function measured by CANTAB
Correlation between cytokines and cognitive function
Measured: 12 weeks
Secondary outcomes (2)
pain inhibition
Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus
Measured: 12 weeks
Allostatic load
Correlation between depressive symptoms, antidepressant treatment status and allostatic load
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Smadar Valerie Tourjman, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391221
- Sponsor's protocol ID
- 2011005
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2011
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study
- ClinicalTrials.gov ID
- NCT01391221
- Acronym / sponsor ID
- 2011005
- Conditions
- Major Depression
- Keywords
- Depression, Inflammation, Cognition, Pain, Allostatic load
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine treatment | Experimental | Drug: DuloxetineSubjects with major depression will be entered into the trial and treated with open label duloxetine |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 20-50 Primary diagnosis of major depression Ability to give informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaSubjects 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 | Drug | Duloxetine treatment |
Primary outcome
Cognitive function measured by CANTAB
Time frame: 12 weeks
Correlation between cytokines and cognitive function
2 secondary outcomes
pain inhibition
Time frame: 12 weeks
Allostatic load
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Major Depression, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Normandeau, Nursing (514-251-4000 ext. 3535, urb.crfs@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function measured by CANTAB (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.