Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03872492
Status:
TERMINATED
Last Update Posted:
2023-03-03
First Post:
2019-02-27
Brief Title:
Major Depressive Disorder Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
Sponsor:
Ad scientiam
Organization:
Ad scientiam
Study Overview
Official Title:
Major Depressive Disorder Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped prematurely because the total number of analyzable patients for the primary objective to be included was reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDRESS
Brief Summary:
Major Depressive Disorder MDD is a debilitating disease characterized by a depressed mood diminished interests impaired cognitive function and vegetative symptoms such as disturbed sleep or appetite MDD occurs about twice as often in women than it does in men and affects about 6 of the adult population worldwide each year
Standard symptoms scales like the Hamilton Depression Rating Scale or the Montgomery-asberg Depression Rating Scale the Self-Report 16-item Quick Inventory of Depressive Symptomatology were initially developed for the evaluation of a therapeutic intervention or a pharmacological treatment and are routinely used by clinicians in the assessment of Treatment Resistant Depression TRD occurrence In parallel patient-reported outcomes have gained increasing importance and are widely recommended by health authorities in the assessment of depression The same institutions insist on the collection of real-world data to provide clinicians with ecological measurements It has been demonstrated that an early response to an AntiDepressant AD treatment can be seen as early as week 2 and is not related to a placebo-effect While there is no consensus on the exact cut-off values several factors emerge as early predictors of a later treatment response such as
Improvement in emotional processing of happy facial expressions after 1 week of treatment
Circa 20 improvement in Hamilton Depression Rating Scale-17 item HDRS-17 at week 2 The hypothesis is therefore that repeated systematic and real-time contextualized and multimodal collection of depressive symptoms from patients at home will establish a threshold score that can predict a subsequent response to their treatment
REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority augmented with digital active and passive activity monitoring speech analysis and emotional processing assessment Another important assumption is that honesty and willingness to disclose personal or embarrassing things will be best achievable via a digital solution
To test this assumption the overall scores and each subscores on the REDRESS numerical scale will be compared in people with MDD showing adequate response to those showing insufficient response
The response to treatment at week 6 will be studied end of Phase 1 Non-responders and responders to the first treatment round will be enrolled in a 6-week extension phase Phase 2 Non-responders will receive another treatment course Other AD combination etc Responders will just be followed up and will keep the same treatment The REDRESS scores will be analysed in this population and will allow us to test the investigators assumption in people with treatment resistant depression This study will also allow to assess patients quality of life at the end of each phase of treatment and to compare results with REDRESS scores
Standard symptoms scales like the Hamilton Depression Rating Scale or the Montgomery-asberg Depression Rating Scale the Self-Report 16-item Quick Inventory of Depressive Symptomatology were initially developed for the evaluation of a therapeutic intervention or a pharmacological treatment and are routinely used by clinicians in the assessment of Treatment Resistant Depression TRD occurrence In parallel patient-reported outcomes have gained increasing importance and are widely recommended by health authorities in the assessment of depression The same institutions insist on the collection of real-world data to provide clinicians with ecological measurements It has been demonstrated that an early response to an AntiDepressant AD treatment can be seen as early as week 2 and is not related to a placebo-effect While there is no consensus on the exact cut-off values several factors emerge as early predictors of a later treatment response such as
Improvement in emotional processing of happy facial expressions after 1 week of treatment
Circa 20 improvement in Hamilton Depression Rating Scale-17 item HDRS-17 at week 2 The hypothesis is therefore that repeated systematic and real-time contextualized and multimodal collection of depressive symptoms from patients at home will establish a threshold score that can predict a subsequent response to their treatment
REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority augmented with digital active and passive activity monitoring speech analysis and emotional processing assessment Another important assumption is that honesty and willingness to disclose personal or embarrassing things will be best achievable via a digital solution
To test this assumption the overall scores and each subscores on the REDRESS numerical scale will be compared in people with MDD showing adequate response to those showing insufficient response
The response to treatment at week 6 will be studied end of Phase 1 Non-responders and responders to the first treatment round will be enrolled in a 6-week extension phase Phase 2 Non-responders will receive another treatment course Other AD combination etc Responders will just be followed up and will keep the same treatment The REDRESS scores will be analysed in this population and will allow us to test the investigators assumption in people with treatment resistant depression This study will also allow to assess patients quality of life at the end of each phase of treatment and to compare results with REDRESS scores
Detailed Description:
None
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