Parcel-guided rTMS for Major Depressive Disorder

Официальное название

Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder

Обзор

Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.

Подробное описание

Standard rTMS treatment often uses the "Beam-F3" targeting approach to locate a brain region known as the left dorsolateral prefrontal cortex (lDLPFC). However, Beam-F3 does not take into account interindividual variation in brain anatomy. Researchers as Columbia University have found a more accurate and personalized approach that uses MRI-based brain surface parcellation to locate the specific subregion of the lDLPFC most ideal for rTMS treatment. Our study is comparing standard rTMS (Beam-F3) to parcel-guided rTMS for patients with treatment resistant depression.

Вмешательства

• Устройство Accelerated rTMS
  rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.
• Устройство Parcel-guided Accelerated rTMS
  rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.

Первичные конечные точки

• Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline and at end of Week 1]

Вторичные конечные точки (3)

• Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS) [Срок оценки: Baseline and at Week 1]
• Side-effect form (SEF) [Срок оценки: Daily from Baseline until Week 1]
• Columbia suicide severity rating scale (C-SSRS) [Срок оценки: Baseline and Week 1]

Критерии участия

Критерии включения

• DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
• Treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ.
• At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20

Критерии исключения

• Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder)
• Anorexia nervosa or bulimia nervosa within the last year
• Unstable medical condition by history, physical exam or laboratory results
• Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
• Contraindications to MRI (based on metal screening form)
• Meets criteria for claustrophobia
• Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
• Neurological or neuromuscular disorder
• Requires medications for a general medical condition that contraindicate the TMS treatment
• Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
• History of ketamine treatment within 6 months
• History of monoamine oxidase inhibitor (MAOI) within the past month
• Lacks capacity to consent
• Taking medications that increase the risk of seizures.
• For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Moreno-Ortega M, Kangarlu A, Lee S, Perera T, Kangarlu J, Palomo T, Glasser MF, Javitt DC. Parcel-guided rTMS for depression. Transl Psychiatry. 2020 Aug 12;10(1):283. doi: 10.1038/s41398-020-00970-8. PMID 32788580

Идентификаторы

NCT: NCT07287839 · RTMSP2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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