Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03701724
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2018-09-17
Brief Title:
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
ACOUSTIM
Brief Summary:
Treatment resistant depression TRD is a frequent debilitating condition mostly treated by antidepressants Repeated magnetic transcranial stimulation rTMS has proven adjuvant efficacy in TRD in the acute phase of treatment with a very good tolerance and acceptability Maintenance rTMS mTMS is a strategy consisting in adding regular single TMS sessions after response to an acute course in order to keep the benefit of initial treatment over several month or years Demonstrating that rTMS is efficient to improve long-term prognosis and decrease economic burden would have a tremendous impact in clinical practice in psychiatry Thus the investigators aim is to analyze the long term impact of mTMS treatment on costs but also quality of life and clinical issues
Detailed Description:
TRD is associated with enormous social economic and personal costs In literature psychosocial and pharmacological interventions showed limited one year long-term efficacy in terms of relapse only 10 of sustained remission at one-year follow-up actually and quality of life due to refractoriness observance and adverse effects In the recent years the field of non-invasive brain stimulation became more mature with an increasing level of evidence reaching Level 1 for rTMS as curative treatment for depression in international guidelines It is a safe and well tolerated treatment but with still high relapse rate at 6 month and one year comparable to those former described for ECT mTMS is a promising tool as it was proven for ECT to achieve sustained response several month after treatment in a significant proportion of patients Little is known about its long-term economic and social benefit which is a crucial question given its time consuming nature To date there is no large Randomized Clinical Trial RCT assessing the long-term health economic interest or adjuvant mTMS compared to treatment as usual TAU alone in unipolar TRD This study is a double-blind randomized controlled trial aiming at determining a 12 month cost-utility analysis according to collective perspective of two different modalities of rTMS systematic mTMS or curative rTMS in case of relapse for TRD compared to TAU alone The secondary aims are to describe 24 month cost-utility longitudinal clinical issues in terms of mood and quality of life prognosis factors as well as TAU actual strategies in that population
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