Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy

Обзор

To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).

Вмешательства

• Устройство Electroconvulsive Therapy
  Electroconvulsive therapy will be administered two to four times a week according to a standardized protocol. Stimulation parameters (including intensity, target location, session number, and duration) will be individualized for each participant based on prior research to ensure targeted and safe delivery within established safety limits. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
• Устройство Magnetic Seizure Therapy
  Magnetic seizure therapy will be administered two to four times a week according to a standardized protocol. Stimulation parameters (including intensity, target location, session number, and duration) will be individualized for each participant based on prior research to ensure targeted and safe delivery within established safety limits. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.

Первичные конечные точки

• Change in Hamilton Depression Rating Scale Total Score. [Срок оценки: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.]
• Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG). [Срок оценки: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.]
• Change in Hamilton Anxiety Rating Scale Total Score. [Срок оценки: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.]
• Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery. [Срок оценки: Baseline and after the completion of the last session (an average of 2 weeks).]

Вторичные конечные точки (1)

• Change in resting-state brain activity in specific brain regions. [Срок оценки: Baseline and after the completion of the last session (an average of 2 weeks).]

Критерии участия

Критерии включения

• Aged 12-80 years;
• Diagnosis confirmed by two psychiatrists per DSM-5;
• Stable medication regimen pre-enrollment;
• Indicated for neuromodulation OR with visual field defects.

Критерии исключения

• Major systemic diseases;
• Prior neuromodulation within 3 months;
• Pregnancy or potential pregnancy;
• Metal implants or claustrophobia.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Anhui Medical University — Хэфэй

Публикации

• Hirano J, Takamiya A, Yamagata B, Hotta S, Miyasaka Y, Pu S, Iwanami A, Uchida H, Mimura M. Frontal and temporal cortical functional recovery after electroconvulsive therapy for depression: A longitudinal functional near-infrared spectroscopy study. J Psychiatr Res. 2017 Aug;91:26-35. doi: 10.1016/j.jpsychires.2017.02.018. Epub 2017 Feb 22. PMID 28292650
• Downey D, Brigadoi S, Trevithick L, Elliott R, Elwell C, McAllister-Williams RH, Anderson IM. Frontal haemodynamic responses in depression and the effect of electroconvulsive therapy. J Psychopharmacol. 2019 Aug;33(8):1003-1014. doi: 10.1177/0269881119858313. Epub 2019 Jun 25. PMID 31237182
• Chhoa KH, Chiang SK, Ong KY, Yong CK, Ng BZ, Othman SZ, McIntyre RS, Choi J, Cha J, Ho RC, Chee KY. Changes in Cerebral Hemodynamic Among Patients With Schizophrenia or Bipolar Disorder Receiving Electroconvulsive Therapy: A Task-Related Functional Near-Infrared Spectroscopy Study. J ECT. 2026 Mar 1;42(1):11-18. doi: 10.1097/YCT.0000000000001110. Epub 2025 Jan 24. PMID 39853313
• Wang W, Lu Y, Mi GL, Li XJ, Zhang DN, Qi SF. Cognitive preservation advantage and efficacy balance of magnetic seizure therapy in adolescent Major Depressive Disorder: a randomized controlled trial revealing efficacy cognition decoupling phenomenon. Riv Psichiatr. 2025 Sep-Oct;60(5):196-201. doi: 10.1708/4583.45901. PMID 41070420
• Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229. PMID 12865903
• Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2. PMID 34131914
• Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Mar 1;81(3):240-249. doi: 10.1001/jamapsychiatry.2023.4599. PMID 38055283
• GBD 2021 Diseases and Injuries Collaborators. Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2133-2161. PMID 38642570

Идентификаторы

NCT: NCT07473648 · AHMU-MST/ECT-MDD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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