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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

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ClinicalTrials.gov Identifier: NCT01903655
Recruitment Status : Unknown
Verified July 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Other: telomere length Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : April 2010
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other: telomere length
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)
Other: telomere length
control group
patient with no depressive disorder during the study period and no psychiatric history
Other: telomere length



Primary Outcome Measures :
  1. Telomere length [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 months ]

Secondary Outcome Measures :
  1. level of oxidative stress. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903655


Locations
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France
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Maud CARPENTIER    03.80.29.35.10    maud.carpentier@chu-dijon.fr   
Principal Investigator: Jean-Christophe CHAUVET-GELINIER         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01903655     History of Changes
Other Study ID Numbers: Chauvet PHRC IR 2009
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms