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Inflammatory Markers and Resistant Depression (InDep)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
psychometric scales
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Depression focused on measuring resistant depression, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA,
  • group 2: patients with MDD remission after response to an antidepressant treatment.

Exclusion Criteria:

  • comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection

Sites / Locations

  • CHU Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

resistant depression

non resistant depression

Arm Description

patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode)

patients in remission from unipolar depressive disorder

Outcomes

Primary Outcome Measures

plasmatic concentration of Interleukin 6

Secondary Outcome Measures

concentration of proinflammatory cytokine
Expression intensity of monocytes costimulation molecules
concentration of antiinflammatory cytokine
functional polymorphisms of expression genes of inflammatory proteins
plasmatic concentration of Retinoid X receptor signaling pathway
Expression rate of monocytes costimulation molecules

Full Information

First Posted
July 21, 2016
Last Updated
July 25, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02847533
Brief Title
Inflammatory Markers and Resistant Depression
Acronym
InDep
Official Title
Inflammatory Markers and Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
resistant depression, inflammation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
resistant depression
Arm Type
Other
Arm Description
patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode)
Arm Title
non resistant depression
Arm Type
Other
Arm Description
patients in remission from unipolar depressive disorder
Intervention Type
Procedure
Intervention Name(s)
blood sample
Intervention Description
blood sample for concentration levels of inflammatory markers
Intervention Type
Behavioral
Intervention Name(s)
psychometric scales
Intervention Description
Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD
Primary Outcome Measure Information:
Title
plasmatic concentration of Interleukin 6
Time Frame
at patient inclusion
Secondary Outcome Measure Information:
Title
concentration of proinflammatory cytokine
Description
Expression intensity of monocytes costimulation molecules
Time Frame
at patient inclusion
Title
concentration of antiinflammatory cytokine
Time Frame
at patient inclusion
Title
functional polymorphisms of expression genes of inflammatory proteins
Time Frame
at patient inclusion
Title
plasmatic concentration of Retinoid X receptor signaling pathway
Time Frame
at patient inclusion
Title
Expression rate of monocytes costimulation molecules
Time Frame
at patient inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA, group 2: patients with MDD remission after response to an antidepressant treatment. Exclusion Criteria: comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Haffen, MD PhD
Phone
0033381218388
Email
ehaffen@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Monnin, PhD
Phone
0033381218543
Email
jmonnin@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Haffen, MD PhD
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Depierre
Phone
03841218745
Email
sdepierre@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel Haffen, MD PhD
First Name & Middle Initial & Last Name & Degree
Pierre Vandel, MD PhD
First Name & Middle Initial & Last Name & Degree
Djamila Bennabi, MD PhD
First Name & Middle Initial & Last Name & Degree
Nazim Nekrouf, MD PhD
First Name & Middle Initial & Last Name & Degree
Julie Giustiniani, MD
First Name & Middle Initial & Last Name & Degree
Caroline Masse-Sibille, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Inflammatory Markers and Resistant Depression

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