Comparing Magnetic Seizure Therapy and Electroconvulsive Therapy for Major Depression

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

This study is testing whether Magnetic Seizure Therapy works better than Electroconvulsive Therapy for treating major depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06409325 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Magnetic Seizure Therapy (MST) compared to Electroconvulsive Therapy (ECT) in treating Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either MST or ECT over a 12-session intervention period, followed by a 12-week observation phase. The study aims to evaluate the efficacy, tolerability, cognitive side effects, and neurophysiological biomarkers associated with both treatments. Clinical observations and EEG/ECG recordings will be conducted to assess outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who meet the diagnostic criteria for MDD and have a baseline Hamilton Depression Rating Scale score of 18 or higher.

Not a fit: Patients with organic brain disorders, neurological disorders, or those currently on medications affecting seizure activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients suffering from Major Depressive Disorder.

How similar studies have performed: Previous studies have shown varying degrees of success with ECT, while MST is a newer approach that requires further investigation.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: TianHong Zhang, Doctor — Shanghai Mental Health Center
• Study coordinator: TianHong Zhang, Doctor

Conditions Major Depressive Disorder; Electroconvulsive therapy; magnetic seizure therapy