Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT04216095
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2019-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This study was a prospective, open-label comparative effectiveness clinical trial, comparing magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).
Detailed Description:
Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than ECT in randomized trials of efficacy. However, there are currently no real-world effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed best for the patient. The aims of this study are to: (1) Evaluate the comparative effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment and treatment response.
Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.
Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.
Study Oversight
Has Oversight DMC:
True
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?: