Major Depression and Messenger RNAs

NCT00998231 | Completed

• 2 other identifiers: 2009/152009-A00405-52
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (2)

Major Depressive Episode (MDE)

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

blood sample BIOLOGICAL

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.

Control; Major Depressive Episode (MDE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique-Hôpitaux de Marseille

Marseille, France

Location

Related Publications (1)

• Belzeaux R, Loundou A, Azorin JM, Naudin J, Ibrahim EC. Longitudinal monitoring of the serotonin transporter gene expression to assess major depressive episode evolution. Neuropsychobiology. 2014;70(4):220-7. doi: 10.1159/000368120. Epub 2015 Jan 9.

  PMID: 25592385 RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Raoul Belzeaux

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: October 20, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Last Updated: May 7, 2026

Record last verified: 2014-02

Locations

FR (1)