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Идёт набор NCT03417960

Accelerated iTBS for Post Partum Depression

Без фазы С лечением Post Partum Depression

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: iTBS.
Кому может быть актуально
Состояния в реестре: Post Partum Depression. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression

Обзор

Study 1: The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm. Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.

Подробное описание

Study 1: This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. The investigators are investigating a 6 day treatment for depression which may be more acceptable for this population. The investigators further aim to characterize the ant-depressant effect of this protocol in order to design a larger trial.

Study 2: In part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8. All other procedures, inclusion/exclusion criteria, and number of total pulses delivered is the same as study 1.

Вмешательства

  • Устройство iTBS
    The investigators will treat post-partum depressed subjects with accelerated intermittent theta burst stimulation. iTBS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. In study 1, the accelerated paradigm will consist of 10 such sessions separated by 15 minutes, for three treatment days per week. There will be 2

Первичные конечные точки

  • Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability). [Срок оценки: 7 days]
Вторичные конечные точки (1)
  • Anti-depressant effect [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  • Participants must be over the age of 18.
  • Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum
  • Participants must have a HRSD17 greater than or equal to 14 at baseline.

Критерии исключения

  • Participants must not be pregnant.
  • Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.
  • Participants must not have current psychotic symptoms.
  • Participants must not have a history of dementia or other cognitive impairment.
  • Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
  • Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).
  • Participants must not have any unstable general medical conditions.
  • Participants must not have had eclampsia during pregnancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT03417960 · Pro00073886

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗