Major Depression and Messenger RNAs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00998231
First received: July 29, 2009
Last updated: February 24, 2014
Last verified: February 2014

July 29, 2009
February 24, 2014
July 2009
September 2012   (final data collection date for primary outcome measure)
to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998231 on ClinicalTrials.gov Archive Site
Not Provided
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Major Depression and Messenger RNAs
Major Depression and Messenger RNAs

Major Depressive Episode (MDE) affects nearly 15% of the general population. In a preliminary study, the investigators identified 12 genes whose expression was either altered between patient and control samples and/or between first patient samples and samples from the same patients obtained 8 weeks later. However, this study did not assess evolution of these alterations beyond an 8-week window and only 2 time points were considered. The investigators aim to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a large time window to draw a better picture of the complex progression during MDE.

Rational:

Major Depressive Episode (MDE) affects nearly 15% of the general population. To date, its pathophysiology remains unclear and treatment effects are often inconsistent. Therefore, it is challenging to make a valid prognosis for depression and identification of biomarkers is an important way of improving patient's treatment. Messenger RNAs (mRNAs) could be potential biological markers. Several studies have shown quantitative variations in peripheral blood mononuclear cells (PBMC) during MDE. These variations are state dependent and/or correlated with clinical measures.

In a preliminary study, the investigators identified 12 genes whose expression was either altered between patient and control samples and/or between first patient samples and samples from the same patients obtained 8 weeks later. However, this study did not assess evolution of these alterations beyond an 8 weeks window and only 2 time points were considered.

Objective:

the investigators aim to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a large time window to draw a better picture of the complex progression during MDE.

Population and method:

This study is longitudinal and comparative. 20 subjects per group will be included and followed during a 6 months interval which includes 4 visits (at the inclusion, 2 and 8 weeks later and finally 6 month later). Clinical observations and psychometric scales will be used for evaluations. Blood collections and PBMCs extraction will be operated after each evaluation and followed by RNA extraction, reverse transcription and gene expression quantification by real-time PCR.

Expected results:

mRNA will be either over or under-expressed in patients during MDE in correlation with the clinical state. There will be no variation across time in control subjects. Comparison between MDE and control will show differences during MDE but not after clinical remission.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Major Depressive Episode
Biological: blood sample
Blood collections and peripheral blood mononuclear cells extraction will be operated after each evaluation and followed by RNA extraction, reverse transcription and gene expression quantification by real-time PCR.
  • Active Comparator: Major Depressive Episode (MDE)
    20 subjects with major depressive episode will be included and followed during a 6 months interval which includes 4 visits (at the inclusion, 2 and 8 weeks later and finally 6 month later)
    Intervention: Biological: blood sample
  • Active Comparator: Control
    20 subjects without major depressive episode will be included and followed during a 6 months interval which includes 4 visits (at the inclusion, 2 and 8 weeks later and finally 6 month later)
    Intervention: Biological: blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Arm MDE:

    • Hamilton score on depression scale (HAMD-17) > 20;
    • No schizophrenia or bipolar disorder or disturbs delirious or evolutionary severe somatic pathology;
    • Taken care by a psychiatric department.
  • Arm control:

    • No history of psychiatric pathology or evolutionary severe somatic pathology

Exclusion Criteria:

  • Arm MDE:

    • Hamilton score on depression scale (HAMD-17) < or = 20;
    • With signs of schizophrenia or bipolar disorder or disturbs delirious;
    • With evolutionary severe somatic pathology.
  • Arm control:

    • With signs of psychiatric pathology or evolutionary severe somatic pathology.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00998231
2009/15, 2009-A00405-52
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Raoul Belzeaux Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP