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

Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01903655
• Other study ID #: Chauvet PHRC IR 2009
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 18, 2013
• Start date: April 2010

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• telomere length

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere length		participants will be followed for the duration of hospital stay, an expected average of 6 months	No
Secondary	level of oxidative stress.		participants will be followed for the duration of hospital stay, an expected average of 6 months	No