NCT06409325

Effectiveness of MST Versus ECT for Major Depressive Episode

Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 ECT/MST, 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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DEVICE	MST	MST was delivered with NS 7000 (Wuhan Yiruide Medical Equipment New Technology Co., Ltd.) using a round coil (125-mm diameter) positioned on the vertex.
DEVICE	ECT	The bitemporal ECT procedure utilized the Thymatron System IV device (Somatics, USA).

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-05-10
• Last updated: 2024-08-22

Locations

1 site across 1 country: China