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Идёт набор NCT05712772

Neuro-affective Response to Light in Depressed Adolescents and Young Adults

Без фазы С лечением Depression in Adolescence Depression in Adults

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: Blue Light, Red Light.
Кому может быть актуально
Состояния в реестре: Depression in Adolescence, Depression in Adults. Базовые параметры: 12 лет — 30 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this neuroimaging pilot study is to understand developmental differences in the impact of therapeutic wavelength light (blue light) versus a non-therapeutic wavelength (red light) on emotional brain function in depression. The main questions this study aims to answer are: * Does acute exposure to blue light (vs red light) stabilize emotional brain function in depressed individuals? * Are stabilizing effects of blue light (vs red light) stronger for blue light in adolescents than young adults? Participants will complete: * A magnetic resonance imaging brain scan, in which we will examine the effect of blue versus red light on emotional brain function at rest and in response to rewards and losses. * A pupillometry test of sensitivity to blue vs red light * Clinical interviews and surveys * Screening measures for drug and alcohol use, MRI safety, and current pregnancy \[if relevant\] * Home sleep tracking with sleep diary and actigraphy for one week

Вмешательства

  • Другое Blue Light
    Blue light exposure
  • Другое Red Light
    Red light exposure

Первичные конечные точки

  • Amygdala cerebral blood flow during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Ventral Striatum cerebral blood flow during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Amygdala activity (loss>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Ventral Striatum activity (punish>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
Вторичные конечные точки (9)
  • Medial prefrontal cortex cerebral blood flow during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Insula cerebral blood flow during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Ventromedial prefrontal cortex cerebral blood flow during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Amygdala-whole brain functional connectivity (loss>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Ventromedial prefrontal cortex activity (loss>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Insula activity (loss>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Medial prefrontal cortex activity (win>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Ventral striatum-whole brain functional connectivity (win>neutral) during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]
  • Ventromedial prefrontal cortex activity, insula, and medial prefrontal activity, and amygdala- and ventral striatum whole brain functional connectivity (response bias; B') during Blue vs Red light exposure [Срок оценки: Collected during the blue and red light exposures during the MRI scan at the lab visit]

Критерии участия

Критерии включения

  • Elevated Depressive Symptoms \[PHQ9≥5 And (Item 1≥1 or Item 2≥1)\]
  • (If <18yr) Parent or guardian can attend the baseline clinical interview

Критерии исключения

  • Unable to read and write in English
  • Intellectual disability.
  • Left or mixed handedness
  • Changes to psychotropic medication type or dosage in the past 2 months
  • Lifetime bipolar disorder or schizophrenia, or substance/alcohol disorder in the past 3 months.
  • Factors influencing light and color sensitivity (i.e., color-blindness, serious ophthalmological conditions, photo-sensitizing medication).
  • Factors influencing the ability to maintain a stable sleep schedule (i.e., shift work, severe sleep disorders, extremely late or early sleep schedule).
  • Severe medical illness, neurological disorders, or history of head trauma.
  • Current pregnancy or nursing
  • MRI contraindication (e.g., metals in the body, recent tattoo, claustrophobia)
  • Positive alcohol or substance use screen at MRI visit

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Western Psychiatric Hospital — Pittsburgh

Идентификаторы

NCT: NCT05712772 · STUDY22040093 · R21MH127294

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗