Effectiveness of MST Versus ECT for Major Depressive Episode

NCT06409325 | Recruiting

• 1 other identifier: NS70002024
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Electroconvulsive therapy (ECT); magnetic seizure therapy (MST)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Device: MST

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.

Device: ECT

Interventions

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.

the MST group

ECT DEVICE

The bitemporal ECT procedure utilized the Thymatron System IV device (Somatics, USA).

the ECT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants who refuse to provide informed consent to participate in the trial will be excluded.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41210143 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• TianHong Zhang, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TianHong Zhang, Doctor

CONTACT

13127577024; zhang_tianhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both clinical staff and participants were blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The present clinical protocol is designed as a double-blind, parallel, non-inferiority, randomized clinical trial.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)