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Major Depression and Messenger RNAs

Primary Purpose

Major Depressive Episode

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Major Depressive Episode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Assistance Publique-Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Major Depressive Episode (MDE)

Control

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects

Secondary Outcome Measures

Full Information

First Posted
July 29, 2009
Last Updated
February 24, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00998231
Brief Title
Major Depression and Messenger RNAs
Official Title
Major Depression and Messenger RNAs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Episode

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Major Depressive Episode (MDE)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
blood sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raoul Belzeaux
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hôpitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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Major Depression and Messenger RNAs

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