CompletedNot Applicable

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

France300 participantsStarted 2010-04

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Telomere length

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 months

Trial details

NCT IDNCT01903655

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Depressive Disorder trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.