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Completed

NCT Number: NCT02209142

Blood Biomarkers in Major Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood prelevement

Other

blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks

psychometric data collection

Other

Other names: psychometric data collection wil be done ( hamilton scale and clinical exam)

Primary outcomes

  1. describe a transcriptional signature of the Major Depressive Episode.

    Time frame: 6 months

    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.

Secondary outcomes

  1. evaluate the role played by confounding factors as genetic polymorphisms,

    Time frame: 6 months

    evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression

Other outcomes

  1. evaluate the role played by confounding factors as immune phenotype

    Time frame: 6 months

    evaluate the role played by confounding factors as immune phenotype to distinguish bipolar from unipolar depression

  2. evaluate the role played by confounding factors as psychotropic medications

    Time frame: 6 months

    evaluate the role played by confounding factors as psychotropic medications to distinguish bipolar from unipolar depression

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2014
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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