NCT02847533

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

July 21, 2016

Last Update Submit

July 25, 2016

Conditions

Depression

Keywords

resistant depressioninflammation

Outcome Measures

Primary Outcomes (1)

  • plasmatic concentration of Interleukin 6

    at patient inclusion

Secondary Outcomes (5)

  • concentration of proinflammatory cytokine

    at patient inclusion

  • concentration of antiinflammatory cytokine

    at patient inclusion

  • functional polymorphisms of expression genes of inflammatory proteins

    at patient inclusion

  • plasmatic concentration of Retinoid X receptor signaling pathway

    at patient inclusion

  • Expression rate of monocytes costimulation molecules

    at patient inclusion

Study Arms (2)

resistant depression

OTHER

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

Procedure: blood sampleBehavioral: psychometric scales

non resistant depression

OTHER

patients in remission from unipolar depressive disorder

Procedure: blood sampleBehavioral: psychometric scales

Interventions

blood samplePROCEDURE

blood sample for concentration levels of inflammatory markers

non resistant depressionresistant depression
psychometric scalesBEHAVIORAL

Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD

non resistant depressionresistant depression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

DepressionInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Emmanuel Haffen, MD PhD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Haffen, MD PhD

CONTACT

0033381218388ehaffen@chu-besancon.fr

Julie Monnin, PhD

CONTACT

0033381218543jmonnin@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 28, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

FR(1)