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Идёт набор NCT06409325

Effectiveness of MST Versus ECT for Major Depressive Episode

Без фазы С лечением Major Depressive Disorder (MDD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MST, ECT.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder (MDD). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • the response rate [Срок оценки: 12 weeks]
  • the remission rate [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Mental Health Center — Шанхай

Публикации

  • 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 PMID 41210143

Идентификаторы

NCT: NCT06409325 · NS70002024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗