Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments blood prelevement, psychometric data collection
Sponsor Assistance Publique Hopitaux De Marseille
Start date February 2012
End date November 2015
Trial size 275 participants
Trial identifier NCT02209142, 2010-19

Summary

Depression is a leading cause of disability worldwide, affecting nearly 16% of the general population. Its physiopathology remains unclear. Based on gene-environment studies and epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE) results from the convergence of multiple factors including biological factors such as multi-genic vulnerability, hormonal and immunological variations as well as environmental factors. As a consequence, mRNA could define a biological signature of the MDE.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
A pan-genomic screen by blood prelevement and psychometric data collection will be set-up on a subset of MDE and control samples to identify mRNA candidates for a transcriptional signature of MDE,
blood prelevement
blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
psychometric data collection psychometric data collection wil be done ( hamilton scale and clinical exam)
(Sham Comparator)
a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
blood prelevement
blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
psychometric data collection psychometric data collection wil be done ( hamilton scale and clinical exam)

Primary Outcomes

Measure
describe a transcriptional signature of the Major Depressive Episode.
time frame: 6 months

Secondary Outcomes

Measure
evaluate the role played by confounding factors as genetic polymorphisms,
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Major depressive disorder at inclusion according to the DSM IV at the time of the inclusion, - Having a score on the scale of depression of Hamilton ( HDRS-17) > 19 at the time of the inclusion, - Taken care by a grown-up psychiatric department, that the coverage(care) is realized in ambulatory or during a hospitalization Exclusion Criteria: - Schizophrenia

Additional Information

Official title Blood Biomarkers in Major Depression
Principal investigator jean Naudin, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.