Magnetic Seizure Therapy for Schizophrenia - Trial

Обзор

This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).

Подробное описание

The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in two academic institutions (the Centre for Addiction and Mental Health (CAMH) in Toronto, and University of British Columbia (UBC) Hospital in Vancouver, British Columbia). The investigators will compare MST to right unilateral ultrabrief pulse ECT (RUL-UB-ECT). Treatment will be administered two to three days per week. Clinical response will be assessed with the 18-item Brief Psychiatric Rating Scale (BPRS). Response will be defined as greater than or equal to 40% decrease in the BPRS positive psychotic symptom subscale (4 items - hallucinatory, behavior, suspiciousness, conceptual disorganization, and unusual thought content). Patients who do not meet response criteria after 15 treatment sessions will be considered non-responders and will cease treatment sessions. The blind will not be broken to participants until the completion of the entire study.

Вмешательства

• Устройство Magnetic Seizure Therapy (MST)
  MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation at 100% machine output. Seizure threshold will follow prior protocols used for frontal MST. Patients will receive care and be managed by anaesthesia as per standard ECT practice.
• Устройство Electroconvulsive Therapy (ECT)
  In the ECT arm treatment, the MECTA spectrum 5000Q or MECTA sigma machine will be used. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold. Patients will receive care and be managed by anaesthesia as per standard ECT practice.

Первичные конечные точки

• Brief Psychiatric Rating Scale (BPRS) Response (18-Version) [Срок оценки: Greater than 8 treatments (2.5 weeks)]
• MATRICS™ Consensus Cognitive Battery (MCCB) [Срок оценки: Greater than 8 treatments (2.5 weeks)]

Вторичные конечные точки (4)

• Scale for Suicidal Ideation (SSI) [Срок оценки: Greater than 8 treatments (2.5 weeks)]
• The Calgary Depression Scale for Schizophrenia (CDSS) [Срок оценки: Greater than 8 treatments (2.5 weeks)]
• Autobiographical Memory Test (AMT) [Срок оценки: Greater than 8 treatments (2.5 weeks)]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: Greater than 8 treatments (2.5 weeks)]

Критерии участия

Критерии включения

• are inpatients or outpatients;
• demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);
• have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);
• are 18 years of age or older;
• have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;
• have a BPRS score at baseline of at least moderate severity (\>4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;
• are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;
• are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;
• are able to adhere to the intervention schedule;
• meet the MST safety criteria;
• If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

Критерии исключения

• have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;
• have a concomitant major unstable medical illness;
• are pregnant or intend to get pregnant during the study;
• 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;
• present with a serious medical condition,
• 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;
• require a benzodiazepine with a dose \> lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
• are unable to communicate in English fluently enough to complete the neuropsychological tests;
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• University of British Columbia Hospital — Vancouver
• Centre for Addiction and Mental Health — Toronto

Идентификаторы

NCT: NCT06672588 · 2105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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