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Inflammatory Markers and Resistant Depression (InDep)

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ClinicalTrials.gov Identifier: NCT02847533
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
plasmatic concentration of Interleukin 6 [ Time Frame: at patient inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inflammatory Markers and Resistant Depression
Official Title  ICMJE Inflammatory Markers and Resistant Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • resistant depression
    patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode)
    Interventions:
    • Procedure: blood sample
    • Behavioral: psychometric scales
  • non resistant depression
    patients in remission from unipolar depressive disorder
    Interventions:
    • Procedure: blood sample
    • Behavioral: psychometric scales
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02847533
Other Study ID Numbers  ICMJE API/2014/50
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel Haffen, MD PhD CHU Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP