Effectiveness of MST Versus ECT for Major Depressive Episode

NCT ID: NCT06409325

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

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.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the MST group

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.

Group Type: EXPERIMENTAL

MST

Intervention Type: 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 ECT group

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.

Group Type: ACTIVE_COMPARATOR

ECT

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

ECT

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Tianhong ZHANG

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TianHong Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

TianHong Zhang, Doctor

Role: CONTACT

zhang_tianhong@126.com

13127577024

Facility Contacts

TianHong Zhang, Doctor

Role: primary

zhang_tianhong@126.com

13127577024

Other Identifiers

NS70002024

Identifier Type: -

Identifier Source: org_study_id