Study of the Telomere-telomerase System and the Expression of Candidate Genes in the Leukocytes of Patients With Depressive Disorder: Search for Peripheral Markers of Somatic Stress

Not Applicable

• Conditions: Depressive Disorder
• Interventions: Other: telomere length

• Registration Number: NCT01903655
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular senescence and are reflected by alterations in systemic gene expression detectable in leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically significant markers. The identification of new genetic markers will make it possible to improve evaluations of the severity and somatic consequences of depressive syndromes.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-18
• Last Update Submitted: 2013-07-18
• Study First Posted: 2013-07-19
• Last Update Posted: 2013-07-19
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Persons who have given their written informed consent
• absence of a diagnosis of major depressive disorder throughout the study and no history of psychiatric disorders
• diagnosis of a first episode of a major depressive disorder
• diagnosis of a recurrent major depressive disorder (at least three episodes) with or without resistance to therapy

Remarks:

• the diagnosis of major depressive disorder with characteristics of melancholy must be clearly mentioned in the case report form but is not a reason for not being included in the study
• the presence of a recent or older attempted suicide must lead to a careful clinical assessment of the diagnosis of depressive disorder and must be clearly mentioned in the case report form.

Exclusion Criteria

• Persons not covered by the national Health Insurance Agency
• Psychotic or bipolar disorders
• Severe personality disorders
• cardiovascular disease, proven inflammatory disease and cancer
• persons unable to give their consent personally,
• persons in emergency situations,
• pregnant women,
• breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with a first episode of major depressive disorder	telomere length	a group of patients with a first episode of major depressive disorder according to DSM-IV-TR including depressive episodes with melancholic features
patients with recurrent depressive disorder	telomere length	a group of patients with recurrent depressive disorder according to DSM-IV-TR including depressive episodes with melancholic features (at least three episodes of depression)
control group	telomere length	patient with no depressive disorder during the study period and no psychiatric history

Primary Outcome Measures

Name	Time	Method
Telomere length	participants will be followed for the duration of hospital stay, an expected average of 6 months

Secondary Outcome Measures

Name	Time	Method
level of oxidative stress.	participants will be followed for the duration of hospital stay, an expected average of 6 months

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France