Blood Biomarkers in Major Depression

Major Depressive Disorder Clinical Trial

Official title:

Blood Biomarkers in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209142
• Other study ID #: 2010-19
• Status: Completed
• Phase: N/A
• Start date: February 22, 2012
• Est. completion date: November 10, 2022

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• blood prelevement
blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
• psychometric data collection

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	evaluate the role played by confounding factors as immune phenotype	evaluate the role played by confounding factors as immune phenotype to distinguish bipolar from unipolar depression	6 months
Other	evaluate the role played by confounding factors as psychotropic medications	evaluate the role played by confounding factors as psychotropic medications to distinguish bipolar from unipolar depression	6 months
Primary	describe a transcriptional signature of the Major Depressive Episode.	The major aim of our study is to compare the expression level of selected genes between patient suffering from major depression and control subjects and within patients across the MDE evolution. We plan to describe a transcriptional signature of the MDE.	6 months
Secondary	evaluate the role played by confounding factors as genetic polymorphisms,	evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression	6 months