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Inflammatory Markers and Resistant Depression (InDep)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02847533
First received: July 21, 2016
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Depression
Procedure: blood sample
Behavioral: psychometric scales

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Inflammatory Markers and Resistant Depression

Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • plasmatic concentration of Interleukin 6 [ Time Frame: at patient inclusion ]

Secondary Outcome Measures:
  • concentration of proinflammatory cytokine [ Time Frame: at patient inclusion ]
    Expression intensity of monocytes costimulation molecules

  • concentration of antiinflammatory cytokine [ Time Frame: at patient inclusion ]
  • functional polymorphisms of expression genes of inflammatory proteins [ Time Frame: at patient inclusion ]
  • plasmatic concentration of Retinoid X receptor signaling pathway [ Time Frame: at patient inclusion ]
  • Expression rate of monocytes costimulation molecules [ Time Frame: at patient inclusion ]

Estimated Enrollment: 108
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02847533

Contacts
Contact: Emmanuel Haffen, MD PhD 0033381218388 ehaffen@chu-besancon.fr
Contact: Julie Monnin, PhD 0033381218543 jmonnin@chu-besancon.fr

Locations
France
CHU Besançon Not yet recruiting
Besançon, France, 25000
Contact: Sophie Depierre    03841218745    sdepierre@chu-besancon.fr   
Principal Investigator: Emmanuel Haffen, MD PhD         
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Emmanuel Haffen, MD PhD CHU Besançon
  More Information

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02847533     History of Changes
Other Study ID Numbers: API/2014/50
Study First Received: July 21, 2016
Last Updated: July 25, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Centre Hospitalier Universitaire de Besancon:
resistant depression
inflammation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 24, 2017