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Идёт набор NCT06294184

TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

Без фазы С лечением Subthreshold Depression Young People Transcranial Direct Current Stimulation

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: tdcs lDLPFC, tdcs rVLPFC, Sham.
Кому может быть актуально
Состояния в реестре: Subthreshold Depression, Young People, Transcranial Direct Current Stimulation. Базовые параметры: 12 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Transcranial Direct Current Stimulation Interventions for Subthreshold Depressive Symptoms in Young Individuals.

Обзор

The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.

Подробное описание

After being informed about the study and potential risks, all participants providing written informed consent will undergo screening to determine eligibility for study entry. On day 0, participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio to receive tDCS targeting the left dorsolateral prefrontal cortex (lDLPFC), tDCS targeting the right ventrolateral prefrontal cortex (rVLPFC), or Sham stimulation (10 sessions in 2 weeks). At baseline, after 2 weeks of stimulation, and at follow-up after 1 month and 3 months, participants will be assessed for brain network function, depressive symptoms, emotional status and social interactions.

Вмешательства

  • Устройство tdcs lDLPFC
    The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.
  • Устройство tdcs rVLPFC
    The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.
  • Устройство Sham
    The current only persist in the fisrt 30s, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3/F6, cathode is on the FP2/1.

Первичные конечные точки

  • The effect of tDCS in alleviating subthreshold depressive symptoms [Срок оценки: 2 weeks, 1 month and 3 months]
Вторичные конечные точки (2)
  • Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms [Срок оценки: 2 weeks, 1 month and 3 months]
  • To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms [Срок оценки: 2 weeks, 1 month and 3 months]

Критерии участия

Критерии включения

  • 1\) Be between the ages of 12-25;
  • 2\) is right-handed on the Edinburgh Handedness Inventory;
  • 3\) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA);
  • 4\) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, \< 24 points;
  • 5\) Gender is not limited;
  • 6\) Subjects and their families voluntarily participate and sign the informed consent form.

Критерии исключения

  • 1\) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL);
  • 2\) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days;
  • 3\) Severe or unstable physical illness;
  • 4\) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
  • 5\) Received transcranial direct current stimulation in the past three months (continuous intervention time: \>2 weeks);
  • 6\) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
  • 7\) Magnetic resonance scanning is contraindicated, such as in vivo metal implants.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Guangzhou Brain hospital(Guangzhou Huiai Hospital) — Гуанчжоу

Идентификаторы

NCT: NCT06294184 · Guangzhou PH tDCS in SD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗