Inflammatory Markers and Cognitive Function in Major Depr... | NCT01391221

Studies
Inflammatory Markers and Cognitive Function in Major Depression

NCT01391221

Sponsor

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

Status

Unknown status

Last Update Posted

Jul 19, 2012Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Major Depression

Interventions

Duloxetine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2012

Last Update Posted Date

Jul 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Smadar Valerie Tourjman, MDCM, FRCPc, MSc, Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duloxetine treatment	Experimental	Subjects with major depression will be entered into the trial and treated with open label duloxetine	Drug: Duloxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function measured by CANTAB	Correlation between cytokines and cognitive function	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
pain inhibition	Correlation between depression, antidepressant treatment status, inflammation and inhibition of perception of pain stimulus	12 weeks
Allostatic load	Correlation between depressive symptoms, antidepressant treatment status and allostatic load

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Louise Normandeau, Nursing	Contact	514-251-4000	3535	urb.crfs@ssss.gouv.qc.ca
Souad Lhalafi, Nursing	Contact	514-251-4000	3416	urb.crfs@ssss.gouv.qc.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Recherche Fernand Seguin	Recruiting	Montreal	Quebec	H1N3V2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression
D007249	Inflammation
D010146	Pain

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068736	Duloxetine Hydrochloride

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided