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.
ECT: The bitemporal ECT procedure utilized the Thymatron System IV device (Somatics, USA).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants must meet the diagnostic criteria for MDD as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
* Participants must have a baseline score of 18 or higher on the 24-item Hamilton Depression Rating Scale (HDRS-24).
* During the trial's treatment period, participants must be using a single antidepressant medication at a stable dose.
* Participants must be between the ages of 18 and 65 years.
* Informed consent from both parents and legal guardians is required.
Exclusion Criteria:
* Individuals with current or history of organic brain disorders or neurological disorders will be excluded from the study.
* Participants with a Wechsler Abbreviated Scale of Intelligence (WASI) score of less than 70 will be excluded.
* Individuals currently taking antiepileptic drugs, benzodiazepines, or other medications that may affect seizure activity will be excluded from the study.
* Those with exposure to ECT, modified ECT, MST, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments in last 6 months will be excluded.
* Individuals with cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain will be excluded from participation.
* Pregnant or lactating individuals will be excluded from the study.
* Individuals currently participating in another concurrent clinical trial will not be eligible for inclusion.
* Participants who refuse to provide informed consent to participate in the trial will be excluded.
* Other circumstances deemed unsuitable for participation by researchers will result in exclusion.
Primary outcome measure(s)
the response rate — 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.
the remission rate — 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai Mental Health Center
Shanghai
Shanghai Municipality
Recruiting
More Shanghai Mental Health Center trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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