Inflammatory Markers and Resistant Depression

NCT ID: NCT02847533

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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resistant depression

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

Group Type OTHER

blood sample

Intervention Type PROCEDURE

blood sample for concentration levels of inflammatory markers

psychometric scales

Intervention Type BEHAVIORAL

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

non resistant depression

patients in remission from unipolar depressive disorder

Group Type OTHER

blood sample

Intervention Type PROCEDURE

blood sample for concentration levels of inflammatory markers

psychometric scales

Intervention Type BEHAVIORAL

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

Interventions

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blood sample

blood sample for concentration levels of inflammatory markers

Intervention Type PROCEDURE

psychometric scales

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Haffen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

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CHU Besançon

Besançon, , France

Site Status

Countries

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France

Central Contacts

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Emmanuel Haffen, MD PhD

Role: CONTACT

0033381218388

Julie Monnin, PhD

Role: CONTACT

0033381218543

Facility Contacts

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Sophie Depierre

Role: primary

03841218745

Other Identifiers

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API/2014/50

Identifier Type: -

Identifier Source: org_study_id

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