Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507787
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Evaluation of the Impact of the EDIT-B Blood Test on the Health Status of Patients Presenting a Major Depressive Episode Clinical Utility and Medico-Economic Aspects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Impact of the EDIT-B Blood Test on the Health Status of Patients Presenting a Major Depressive Episode Clinical Utility and Medico-Economic Aspects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEM EDIT-B
Brief Summary:
Depression is one of the most common mental disorders affecting nearly 10 of men and 20 of women worldwide It is associated with a significant increase in mortality mainly due to suicidal behavior The Diagnostic and Statistical Manual of Mental Disorders DSM defines a Major Depressive Episode MDE by a combination of at least five different symptoms with at least one depressed mood or loss of interest MDEs can occur in isolation or as part of Major Depressive Disorder MDD or bipolar disorder BD Bipolar disorders affect 2 of the worlds population and are defined by episodes of mania Type I BD or hypomania Type II BD alternating with episodes of depression and periods of remission
Depression occurring whether in the context of BD or MDD is defined with the same clinical criteria However the pharmacological treatments are different in the two groups In particular antidepressants prescribed without a thymoregulator in bipolar patients can lead to a worsening of the episode favoring suicidal behavior or a manic turn
The average interval between the onset of BD symptoms and appropriate diagnosis is estimated to be approximately 7 years which delays appropriate management and treatment and increases the risk of suicide
Biological markers able to differentiate between the different types of depression were lacking before the advent of EDIT-B one of the main objectives of this research is to measure the clinical impact of the use of EDIT-B in the short and medium term on the management of patients with BD and major depression The health economic aspect will also be considered
In total 450 patients in two different groups EDIT-B group and control group will be recruited over a study timeline of 24 months Study participation is over 6 months with 4 visits
Depression occurring whether in the context of BD or MDD is defined with the same clinical criteria However the pharmacological treatments are different in the two groups In particular antidepressants prescribed without a thymoregulator in bipolar patients can lead to a worsening of the episode favoring suicidal behavior or a manic turn
The average interval between the onset of BD symptoms and appropriate diagnosis is estimated to be approximately 7 years which delays appropriate management and treatment and increases the risk of suicide
Biological markers able to differentiate between the different types of depression were lacking before the advent of EDIT-B one of the main objectives of this research is to measure the clinical impact of the use of EDIT-B in the short and medium term on the management of patients with BD and major depression The health economic aspect will also be considered
In total 450 patients in two different groups EDIT-B group and control group will be recruited over a study timeline of 24 months Study participation is over 6 months with 4 visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None