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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the MST group | Experimental | MST was conducted at 100 Hz and 100% output using a pulse width of 350 μs and a peak intensity of the magnetic field at 3.0 Tesla. The duration of magnetic stimulation was titrated using a 10-second train duration, starting from 2 seconds and increasing by 4 seconds in subsequent sessions, up to a maximum of 10 seconds (i.e., 200-1,000 pulses per session). In cases of poor seizure quality (<15 s), the stimulation duration increment was set to 6 seconds in the next session. If no seizures were elicited, an additional 10-second stimulation was administered immediately. Subsequent MST treatments were maintained at a 10-second duration for a total of 1000 pulses. |
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| the ECT group | Active Comparator | For ECT, the pulse width of the electrical stimulus was set to 0.5 ms. The initial energy dosage was determined based on the patient's age, with subsequent sessions increasing by 5% increments. In cases of inadequate seizure duration (<25 s), the maximum dosage was administered in the following session. If no seizures were induced, the maximum dosage was administered immediately. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MST | Device | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| the response rate | 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. | 12 weeks |
| the remission rate | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TianHong Zhang, Doctor | Contact | 13127577024 | zhang_tianhong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| TianHong Zhang, Doctor | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41210143 | Derived | Zhang T, He Y, Liu S, Ju M, Yang Y, Zhou R, Hong Y, Wei Y, Tang X, Zheng H, Jia Y, Liu H, Zhou D, Hu Q, Wang R, Zheng W, Zeng L, An C, Li C, Wang J. Effectiveness of magnetic seizure therapy versus electroconvulsive therapy for major depressive episode in China: protocol for a double-blind, randomized, non-inferiority trial. Front Psychiatry. 2025 Oct 23;16:1657906. doi: 10.3389/fpsyt.2025.1657906. eCollection 2025. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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The present clinical protocol is designed as a double-blind, parallel, non-inferiority, randomized clinical trial.
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Both clinical staff and participants were blinded to the treatment assignment.
| ECT | Device | The bitemporal ECT procedure utilized the Thymatron System IV device (Somatics, USA). |
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