Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02830399
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2016-06-08
Brief Title:
Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression
Sponsor:
Centre Hospitalier du Rouvray
Organization:
Centre Hospitalier du Rouvray
Study Overview
Official Title:
Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation rTMS to Improve Electroconvulsive Therapy ECT in Treatment-Resistant Depression TRD STIMAGNECT Study
Status:
COMPLETED
Status Verified Date:
2021-02
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:
STIMAGNECT
Brief Summary:
Its a prospective multicentric randomized controlled study concerning 56 patients with treatment-resistant depression TRD The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation rTMS sessions before Electroconvulsive therapy ECT for treatment of TRD patients The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression HAMD-21 items after 5 ECT The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association
Detailed Description:
Included patients are adults aged between 18 and 70 years with major depression Hamilton Rating scale for Depression HAMD 15 Patients dont have any experience concerning repeated Transcranial Magnetic Stimulation rTMS
Patients with treatment-resistant depression TRD were assigned to two treatment groups in addition to their current pharmacotherapy regimen one group received 5 active-rTMS before Electroconvulsive therapy ECT and the other one received sham-rTMS before ECT The depressive symptoms and the cognitive functions are evaluated before rTMS after 5 rTMS and after 5 ECT
Patients with treatment-resistant depression TRD were assigned to two treatment groups in addition to their current pharmacotherapy regimen one group received 5 active-rTMS before Electroconvulsive therapy ECT and the other one received sham-rTMS before ECT The depressive symptoms and the cognitive functions are evaluated before rTMS after 5 rTMS and after 5 ECT
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