Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05952674
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-19
First Post:
2021-05-27
Brief Title:
Treatment Resistant Depression and Vagus Nerve Stimulation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Resistant Depression and Vagus Nerve Stimulation a Medico-economic Multicenter Randomized and Open Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
DepVNS
Brief Summary:
Depression is a common illness affecting 17 of the population over the course of a lifetime A third of depressions relapses and progresses to recurrence and resistance to treatments Despite the optimization of antidepressant medical strategies 20 to 40 of depressions do not respond to treatment This is particularly worrying as 6 of non-responder patients will die by committing suicide
Depression has a major impact on quality of life socio-professional functioning and healthcare consumption
Sometimes TRD is part of a bipolar illness In this case the challenge is even bigger because antidepressants are no well tolerated further reducing the therapeutic options in case of resistance the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients
The standard treatment for TRD is electroconvulsive therapy ECT which results in a response in 60 to 70 of cases after a few weeks of treatment However the improvement is often transient and 40 of patients relapse within 6 months of the initial ECT session Moreover ECT is often not well tolerated This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response
The literature suggests that Vagus Nerve Stimulation VNS has unique kinetics of efficacy in depression particularly in preventing long-term recurrences and therefore responding to the lack of effective maintenance treatment in TRD In fact the benefits of VNS gradually accumulate over 12-24 months which makes it complementary to more incisive treatments like ECT Finally its efficacy-tolerance profile appears to be similar in uni and bipolar TRD giving VNS a potentially unique place in the therapeutic arsenal in psychiatry
The DepVNS hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment
The primary objective is to estimate from a collective point of view the incremental cost-utility ratio of VNS to treat patients suffering from RD
Depression has a major impact on quality of life socio-professional functioning and healthcare consumption
Sometimes TRD is part of a bipolar illness In this case the challenge is even bigger because antidepressants are no well tolerated further reducing the therapeutic options in case of resistance the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients
The standard treatment for TRD is electroconvulsive therapy ECT which results in a response in 60 to 70 of cases after a few weeks of treatment However the improvement is often transient and 40 of patients relapse within 6 months of the initial ECT session Moreover ECT is often not well tolerated This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response
The literature suggests that Vagus Nerve Stimulation VNS has unique kinetics of efficacy in depression particularly in preventing long-term recurrences and therefore responding to the lack of effective maintenance treatment in TRD In fact the benefits of VNS gradually accumulate over 12-24 months which makes it complementary to more incisive treatments like ECT Finally its efficacy-tolerance profile appears to be similar in uni and bipolar TRD giving VNS a potentially unique place in the therapeutic arsenal in psychiatry
The DepVNS hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment
The primary objective is to estimate from a collective point of view the incremental cost-utility ratio of VNS to treat patients suffering from RD
Detailed Description:
Depression is a common illness affecting 17 of the population over the course of a lifetime A third of depressions relapses and progresses to recurrence and resistance to treatments Despite the optimization of antidepressant medical strategies 20 to 40 of depressions do not respond to treatment This is particularly worrying as 6 of non-responder patients will die by committing suicide The term treatment-resistant depression TRD is used when two or more and often many more well conducted antidepressant treatments from different classes have failed to achieve remission
Depression has a major impact on quality of life socio-professional functioning and healthcare consumption According to the World Health Organization WHO depression will be the second cause of healthcare costs in the world by 2020 RD alone accounts for 30 to 40 of the annual cost of depression
Sometimes TRD is part of a bipolar illness a psychiatric condition characterized by the alternation of depressive and maniac episodes that affects 4 of the population In this case the challenge is even bigger because 1 antidepressants are no well tolerated further reducing the therapeutic options in case of resistance 2 the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients Bipolar RD currently accounts for 20 of all psychiatric spending
The standard treatment for TRD is electroconvulsive therapy ECT which results in a response in 60 to 70 of cases after a few weeks of treatment However the improvement is often transient and 40 of patients relapse within 6 months of the initial ECT session Moreover ECT is often not well tolerated because of the frequency and the intensity of the memory disorders associated the repetition of anesthesia and hospitalizations and its social stigma Refusals and requests to stop ECT are therefore common even when it is effective as these constraints are sometimes experienced as being unbearable in the long-term This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response
The literature suggests that Vagus Nerve Stimulation VNS has unique kinetics of efficacy in depression particularly in preventing the long-term recurrences and therefore responding to the lack of effective maintenance treatment in TRD In fact the benefits of VNS gradually accumulate over 12-24 months which makes it complementary to more incisive treatments like ECT Finally its efficacy-tolerance profile appears to be similar in uni and bipolar TRD giving VNS a potentially unique place in the therapeutic arsenal in psychiatry VNS has been approved for over 15 years as a treatment for RD in the Unites States and Great-Britain
The hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment
The primary objective is to estimate from a collective point of view the incremental cost-utility ratio of VNS to treat patients suffering from RD
The secondary objectives are evaluating the efficacy and the security of the VNS as well as positioning the VNS in comparison with ECT that is currently the standard treatment for TRD
This is a national multicenter comparative open randomized controlled two-parallel group clinical trial evaluating the medico-economic impact of VNS in resistant depression population Patients 166 suffering from resistant depression will be enrolled over a 24-month period and will be randomized in a 11 ratio to receive either Vagus Nerve Stimulation VNS along with the Best Medical Treatment VNSBMT arm or the Optimal Medical Treatment only BMT arm
Patients meeting all eligibility criteria will be enrolled in the study
All subjects will be followed by the investigators or designee of the investigator during the whole study period by visits on site
Number of visitsparticipant Both arms will attend selection visit VS inclusion visit VI and randomization visit R M0 M2 M4 M6 M8 M10 M12 M14 M16 M18 M20 M22 and M24 After the inclusion visit the experimental arm VNS BMT will further attend a neurosurgical and anesthetic consultation before being hospitalized for the VNS system placement The patient will finally be hospitalized in psychiatry for about 5 days for switching the device on If the target intensity has not been reached during this hospitalization an adjustment visit is planned every month for 6 months in order to progressively increase the stimulation intensity until the target or a therapeutic response If the target or the therapeutic response is obtained the settings adjustments rhythm will be at the indiscretion of the psychiatrist If at the end of the 6 first visits M1 to M6 the target intensity couldnt be reached or in absence of a satisfying clinical response a visit will be planned every 3 months consultation or hospitalization to keep optimizing the VNS
Depression has a major impact on quality of life socio-professional functioning and healthcare consumption According to the World Health Organization WHO depression will be the second cause of healthcare costs in the world by 2020 RD alone accounts for 30 to 40 of the annual cost of depression
Sometimes TRD is part of a bipolar illness a psychiatric condition characterized by the alternation of depressive and maniac episodes that affects 4 of the population In this case the challenge is even bigger because 1 antidepressants are no well tolerated further reducing the therapeutic options in case of resistance 2 the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients Bipolar RD currently accounts for 20 of all psychiatric spending
The standard treatment for TRD is electroconvulsive therapy ECT which results in a response in 60 to 70 of cases after a few weeks of treatment However the improvement is often transient and 40 of patients relapse within 6 months of the initial ECT session Moreover ECT is often not well tolerated because of the frequency and the intensity of the memory disorders associated the repetition of anesthesia and hospitalizations and its social stigma Refusals and requests to stop ECT are therefore common even when it is effective as these constraints are sometimes experienced as being unbearable in the long-term This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response
The literature suggests that Vagus Nerve Stimulation VNS has unique kinetics of efficacy in depression particularly in preventing the long-term recurrences and therefore responding to the lack of effective maintenance treatment in TRD In fact the benefits of VNS gradually accumulate over 12-24 months which makes it complementary to more incisive treatments like ECT Finally its efficacy-tolerance profile appears to be similar in uni and bipolar TRD giving VNS a potentially unique place in the therapeutic arsenal in psychiatry VNS has been approved for over 15 years as a treatment for RD in the Unites States and Great-Britain
The hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment
The primary objective is to estimate from a collective point of view the incremental cost-utility ratio of VNS to treat patients suffering from RD
The secondary objectives are evaluating the efficacy and the security of the VNS as well as positioning the VNS in comparison with ECT that is currently the standard treatment for TRD
This is a national multicenter comparative open randomized controlled two-parallel group clinical trial evaluating the medico-economic impact of VNS in resistant depression population Patients 166 suffering from resistant depression will be enrolled over a 24-month period and will be randomized in a 11 ratio to receive either Vagus Nerve Stimulation VNS along with the Best Medical Treatment VNSBMT arm or the Optimal Medical Treatment only BMT arm
Patients meeting all eligibility criteria will be enrolled in the study
All subjects will be followed by the investigators or designee of the investigator during the whole study period by visits on site
Number of visitsparticipant Both arms will attend selection visit VS inclusion visit VI and randomization visit R M0 M2 M4 M6 M8 M10 M12 M14 M16 M18 M20 M22 and M24 After the inclusion visit the experimental arm VNS BMT will further attend a neurosurgical and anesthetic consultation before being hospitalized for the VNS system placement The patient will finally be hospitalized in psychiatry for about 5 days for switching the device on If the target intensity has not been reached during this hospitalization an adjustment visit is planned every month for 6 months in order to progressively increase the stimulation intensity until the target or a therapeutic response If the target or the therapeutic response is obtained the settings adjustments rhythm will be at the indiscretion of the psychiatrist If at the end of the 6 first visits M1 to M6 the target intensity couldnt be reached or in absence of a satisfying clinical response a visit will be planned every 3 months consultation or hospitalization to keep optimizing the VNS
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