Magnetic Seizure Therapy for Psychotic Disorders

Официальное название

Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders

Обзор

This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Подробное описание

Psychosis is recognized as one of the largest contributors to nonfatal health loss, and substantial portion of patients exhibit resistance to antipsychotics, emphasizing the need for exploring non-pharmacological treatments. In clinical practice, Electroconvulsive therapy (ECT) has been shown to be generally effective in psychosis, but its clinical use sometimes is limited by its cognitive side effects. Magnetic Seizure Therapy (MST) is a novel modification of electroconvulsive therapy (ECT). MST offers the advantages of milder side effects on cognition, a quicker return of orientation, and a shorter duration of post-ictal confusion. A few studies have studied the antipsychotic effect of MST. Therefore, the present study will plan to perform a clinical trial to compare the efficacy of MST treatment plus antipsychotics to antipsychotic medications alone among psychotic disorders in acute phase. In addition, whether MST treatment plus antipsychotics will bring a quicker efficacy response than antipsychotic medications alone is also of important clinical significance. The present trial will plan to administer 10 sessions of MST in 2 weeks, in which the patients will be randomly allocated to either receiving MST+medications or receiving medications alone. After the 2 week's research intervention, all patients will be switched to clinical routine management, but kept under masked clinical assessment for 4 weeks.

Вмешательства

• Устройство Magnetic seizure therapy by Magnetic stimulator
  The seizure is induced by Magnetic stimulator of MagPro MST(XP)，MagVenture A/S, Farum, Denmark. It is administered in combinations with antipsychotic medications
• Препарат Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)
  It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.

Первичные конечные точки

• Changes in Positive and Negative Symptom Scale (PANSS) [Срок оценки: Baseline, 1 weeks, 2 weeks, 6 weeks]

Вторичные конечные точки (9)

• Changes in cognition [Срок оценки: Baseline, 1 weeks, 2 weeks]
• Changes of ictal EEG feature [Срок оценки: during each treatment]
• Changes of cortical inhibition [Срок оценки: baseline, 2 weeks]
• Changes of brain grey matter [Срок оценки: baseline, 2 weeks]
• Changes in 24-item Hamilton Depression Rating Scale (HAM-D) [Срок оценки: Baseline, 1 weeks, 2 weeks, 6 weeks]
• Changes in Hamilton Anxiety Scale (HAMA) [Срок оценки: Baseline, 1 weeks, 2 weeks, 6 weeks]
• Changes in Clinical Global Impression (CGI) scale [Срок оценки: Baseline, 2 weeks, 6 weeks]
• Changes in Global Assessment of Functioning (GAF) scale [Срок оценки: Baseline, 2 weeks, 6 weeks]
• Changes in brain gamma band signal [Срок оценки: Baseline, 2 weeks]

Критерии участия

Критерии включения

• (1) meets the diagnostic criteria for schizophrenia or other primary psychotic disorders according to DSM-5;
• (2) age range between 18 and 55 years;
• (3) Positive And Negative Syndrome Scale (PANSS) score≥60;
• (4) to provide informed consent.

Критерии исключения

• (1) have a concomitant severe medical illness;
• (2) are pregnant or intend to get pregnant during the study;
• (3) have a history of DSM-5 diagnosis of substance dependence or abuse within the past three months;
• (4) history of traumatic brain injury (with a screening scale score of 7 or above);
• (5) history of poor response to electroconvulsive therapy or MST;
• (6) have probable dementia based on study investigator assessment; have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
• (7) presenting with a medical condition, medication, or laboratory anomaly deemed by the investigator to potentially induce psychotic symptoms, or significant cognitive impairment. (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
• (8) have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
• (9) a score of 18 or more on the 24-item Hamilton Depression Rating Scale (HAM-D);
• (10) needing ECT treatment immediately due to such dangerous symptoms as suicide, stupor or psychomotor agitation, etc.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shanghai Mental Health Center — Шанхай
• Shanghai Mental Health Center — Шанхай

Публикации

• Jiang J, Li J, Xu Y, Zhang B, Sheng J, Liu D, Wang W, Yang F, Guo X, Li Q, Zhang T, Tang Y, Jia Y, Daskalakis ZJ, Wang J, Li C. Magnetic Seizure Therapy Compared to Electroconvulsive Therapy for Schizophrenia: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 25;12:770647. doi: 10.3389/fpsyt.2021.770647. eCollection 2021. PMID 34899429
• Jiang J, Li Q, Sheng J, Yang F, Cao X, Zhang T, Jia Y, Wang J, Li C. 25 Hz Magnetic Seizure Therapy Is Feasible but Not Optimal for Chinese Patients With Schizophrenia: A Case Series. Front Psychiatry. 2018 May 29;9:224. doi: 10.3389/fpsyt.2018.00224. eCollection 2018. PMID 29896130
• Daskalakis ZJ, Tamminga C, Throop A, Palmer L, Dimitrova J, Farzan F, Thorpe KE, McClintock SM, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy. Trials. 2021 Nov 8;22(1):786. doi: 10.1186/s13063-021-05730-7. PMID 34749782
• Daskalakis ZJ, McClintock SM, Hadas I, Kallioniemi E, Zomorrodi R, Throop A, Palmer L, Farzan F, Thorpe KE, Tamminga C, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology. Trials. 2021 Dec 11;22(1):906. doi: 10.1186/s13063-021-05873-7. PMID 34895296

Идентификаторы

NCT: NCT06581302 · 2023-TX-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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