Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409325
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-07
Brief Title:
Effectiveness of MST Versus ECT for Major Depressive Episode
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Despite advancements in Magnetic Seizure Therapy MST and Electroconvulsive Therapy ECT for Major Depressive Disorder MDD there remains a need for further research to replicate clinical outcomes and understand the therapeutic targets of these treatments This study aims to address these gaps through a double-blinded randomized non-inferiority investigation comparing the efficacy tolerability cognitive adverse effects and neurophysiological biomarkers of MST and bilateral ECT in patients with MDD
Detailed Description:
Participants will be randomly allocated to either the ECT or MST group Each center aims to recruit 30 participants for each group using block randomization resulting in a total of 30 participants per group The trial comprises a 12-session intervention phase of ECTMST spanning approximately 4 weeks followed by a 12-week observation period For the first three treatment sessions participants will receive consecutive sessions Subsequently there will be a one-day interval between sessions 4 to 6 a two-day interval between sessions 7 to 9 and a three-day interval between sessions 10 to 12 ensuring completion within a month Following treatment completion participants will undergo follow-up clinical observations every four weeks for 12 weeks EEG and ECG recordings will be obtained at baseline post-session 3 6 9 12 3 hours after each session and at the 12-week follow-up All evaluations will be conducted under standardized conditions throughout the sessions
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