Inflammatory Markers and Resistant Depression

Depression Clinical Trial

— InDep  

Official title:

Inflammatory Markers and Resistant Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02847533
• Other study ID #: API/2014/50
• Status: Not yet recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: July 25, 2016
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Emmanuel Haffen, MD PhD
• Phone: 0033381218388
• Email: ehaffen[@]chu-besancon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasmatic concentration of Interleukin 6		at patient inclusion	No
Secondary	concentration of proinflammatory cytokine	Expression intensity of monocytes costimulation molecules	at patient inclusion	No
Secondary	concentration of antiinflammatory cytokine		at patient inclusion	No
Secondary	functional polymorphisms of expression genes of inflammatory proteins		at patient inclusion	No
Secondary	plasmatic concentration of Retinoid X receptor signaling pathway		at patient inclusion	No
Secondary	Expression rate of monocytes costimulation molecules		at patient inclusion	No