Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05866991
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-01-12
Brief Title:
Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep Circadian Rhythms and Psychiatric Disorders
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep Circadian Rhythms and Psychiatric Disorders
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoPsy-SoSad
Brief Summary:
Despite international efforts to identify biomarkers of depression none has been transferred to clinical practice neither for diagnosis evolution nor therapeutic response This led us to build a French national cohort through the clinical and research network named SoPsy within the French biological psychiatry society AFPBN and sleep society SFRMS to better identify markers of sleep and biological rhythms and validate more homogeneous subgroups of patients but also to specify the manifestations and pathogeneses of depressive disorders
Detailed Description:
Depressive disorders are a group of frequent and severe disorders that affect up to 20 of the general population The WHO projects that depression will be the leading cause of disability by 2030 This growing public health problem is marked by a decrease in psychosocial functioning and quality of life and is associated with a high rate of suicide In addition there is a significant economic impact including loss of productivity and a significant increase in the use of health care services To date the diagnosis of a depressive episode is based solely on clinical assessment and diagnostic criteria Despite international efforts to identify biomarkers of depression none of these identified biomarkers have been transferred to clinical practice either for diagnosis outcome or treatment prediction Some of the difficulties and lack of replication of certain results are directly related to the nature of depressive disorders which include a large number of very heterogeneous entities
Among the markers of interest in patients with a major depressive episode MDE the scientific literature has shown close links between depression and disturbances in sleep and biological rhythms Thus more than 90 of patients suffering from MDE have sleep complaints PMID28972930 Moreover it is now well demonstrated via epidemiological and longitudinal follow-up studies that sleep disorders and in particular insomnia are both risk factors and prodromes of MDE These sleep and rhythm abnormalities seem to persist during remission phases and appear to be risk factors for depressive recurrence Objective abnormalities assessed by actigraphy and polysomnography have also been demonstrated during episodes and in subjects at risk of depression and thus appear to be both state and trait markers of the disorder These sleep and circadian rhythm abnormalities in addition to being associated with depressive relapse are associated with poor global functioning poor quality of life and risk of metabolic syndrome
Moreover depressive disorders encompass a very heterogeneous set of conditions and these biomarkers seem to hold great promise for better characterising the different subtypes of disorders and for better characterising patient populations Finally these clinical observations make sleep and circadian rhythm abnormalities essential therapeutic targets making it possible to propose a truly more personalised medicine in psychiatry
It is therefore urgent to better characterise the different subtypes of depressive disorders and to better understand the pathogenesis and evolution of these disorders in order to have predictive markers for conversion recurrence or therapeutic responses The objective of identifying such markers would also ultimately be to better screen patients and to propose adapted and personalised therapeutic strategies The constitution of a national cohort with a fine and homogeneous characterisation between the centres is intended to meet these objectives by assessing psychiatry addiction sleep and chronobiology dimensions of depressive disorders
Among the markers of interest in patients with a major depressive episode MDE the scientific literature has shown close links between depression and disturbances in sleep and biological rhythms Thus more than 90 of patients suffering from MDE have sleep complaints PMID28972930 Moreover it is now well demonstrated via epidemiological and longitudinal follow-up studies that sleep disorders and in particular insomnia are both risk factors and prodromes of MDE These sleep and rhythm abnormalities seem to persist during remission phases and appear to be risk factors for depressive recurrence Objective abnormalities assessed by actigraphy and polysomnography have also been demonstrated during episodes and in subjects at risk of depression and thus appear to be both state and trait markers of the disorder These sleep and circadian rhythm abnormalities in addition to being associated with depressive relapse are associated with poor global functioning poor quality of life and risk of metabolic syndrome
Moreover depressive disorders encompass a very heterogeneous set of conditions and these biomarkers seem to hold great promise for better characterising the different subtypes of disorders and for better characterising patient populations Finally these clinical observations make sleep and circadian rhythm abnormalities essential therapeutic targets making it possible to propose a truly more personalised medicine in psychiatry
It is therefore urgent to better characterise the different subtypes of depressive disorders and to better understand the pathogenesis and evolution of these disorders in order to have predictive markers for conversion recurrence or therapeutic responses The objective of identifying such markers would also ultimately be to better screen patients and to propose adapted and personalised therapeutic strategies The constitution of a national cohort with a fine and homogeneous characterisation between the centres is intended to meet these objectives by assessing psychiatry addiction sleep and chronobiology dimensions of depressive disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None