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NCT Number: NCT06409325

Effectiveness of MST Versus ECT for Major Depressive Episode

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

TianHong Zhang, Doctor

CONTACT

[email protected]

13127577024

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

ECT

Device

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

Primary outcomes

  1. the response rate

    Time frame: 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.

  2. the remission rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

TianHong Zhang, Doctor

CONTACT

[email protected]

13127577024

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 10, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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