Inflammatory Markers and Resistant Depression (InDep)

July 25, 2016 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon
        • Contact:
        • Sub-Investigator:
          • Pierre Vandel, MD PhD
        • Sub-Investigator:
          • Djamila Bennabi, MD PhD
        • Sub-Investigator:
          • Nazim Nekrouf, MD PhD
        • Sub-Investigator:
          • Julie Giustiniani, MD
        • Sub-Investigator:
          • Caroline Masse-Sibille, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: resistant depression
patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode)
Procedure: blood sample
blood sample for concentration levels of inflammatory markers
Behavioral: psychometric scales
Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD
Other: non resistant depression
patients in remission from unipolar depressive disorder
Procedure: blood sample
blood sample for concentration levels of inflammatory markers
Behavioral: psychometric scales
Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasmatic concentration of Interleukin 6
Time Frame: at patient inclusion
at patient inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of proinflammatory cytokine
Time Frame: at patient inclusion
Expression intensity of monocytes costimulation molecules
at patient inclusion
concentration of antiinflammatory cytokine
Time Frame: at patient inclusion
at patient inclusion
functional polymorphisms of expression genes of inflammatory proteins
Time Frame: at patient inclusion
at patient inclusion
plasmatic concentration of Retinoid X receptor signaling pathway
Time Frame: at patient inclusion
at patient inclusion
Expression rate of monocytes costimulation molecules
Time Frame: at patient inclusion
at patient inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Emmanuel Haffen, MD PhD, CHU Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2014/50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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