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

NCT ID: NCT01903655

Last Updated: 2013-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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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

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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patients with a first episode of major depressive disorder

a group of patients with a first episode of major depressive disorder according to DSM-IV-TR including depressive episodes with melancholic features

Group Type OTHER

telomere length

Intervention Type OTHER

patients with recurrent depressive disorder

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)

Group Type OTHER

telomere length

Intervention Type OTHER

control group

patient with no depressive disorder during the study period and no psychiatric history

Group Type OTHER

telomere length

Intervention Type OTHER

Interventions

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telomere length

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Dijon

Dijon, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Maud CARPENTIER

Role: primary

03.80.29.35.10

Other Identifiers

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Chauvet PHRC IR 2009

Identifier Type: -

Identifier Source: org_study_id

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