Major Depression and Messenger RNAs
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Major Depressive Episode |
Biological: blood sample |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Major Depression and Messenger RNAs |
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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: 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)
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Raoul Belzeaux | raoul.belzeaux@ap-hm.fr |
| France | |
| Assistance Publique-Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Raoul Belzeaux raoul.belzeaux@ap-hm.fr | |
| Principal Investigator: Raoul Belzeaux | |
| Principal Investigator: | Raoul Belzeaux | Assistance Publique Hopitaux De Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique-Hôpitaux de Marseille, Direction de la recherche |
| ClinicalTrials.gov Identifier: | NCT00998231 History of Changes |
| Other Study ID Numbers: | 2009/15, 2009-A00405-52 |
| Study First Received: | July 29, 2009 |
| Last Updated: | October 19, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013