Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
NCT Number: NCT06409325
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The bitemporal ECT procedure utilized the Thymatron System IV device (Somatics, USA).
Time frame: 12 weeks
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the response rate is defined as a reduction of at least 50% in the HDRS-24 score from baseline.
Time frame: 12 weeks
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the remission rate is defined as a reduction of at least 60% in the HDRS-24 score and a total score of 8 or less.
Contact information is provided by the study sponsor or research team.
Shanghai Mental Health Center
Other
Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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