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Идёт набор NCT07111390

Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

Без фазы С лечением Depression MDD Major Depressive Disorder Major Depressive Episode

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: 60Hz Intermittent Light Therapy, Sham Light Therapy.
Кому может быть актуально
Состояния в реестре: Depression, MDD, Major Depressive Disorder, Major Depressive Episode. Базовые параметры: 24 лет — 65 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
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Официальное название

A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression

Обзор

This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.

Подробное описание

This pilot study will evaluate the tolerability, usability, and preliminary impact of a novel wearable device delivering 60Hz intermittent light for treatment of depressive symptoms in adults with MDD. All procedures are conducted remotely.

Вмешательства

  • Устройство 60Hz Intermittent Light Therapy
    Intermittent 60 Hz flickering white light delivered via a wearable headset.
  • Устройство Sham Light Therapy
    Constant white light delivered via a wearable headset.

Первичные конечные точки

  • Proportion of Participants who Complete all Scheduled Sessions [Срок оценки: Up to Week 3]
  • Average Percentage of Completed Sessions [Срок оценки: Up to Week 3]
  • Proportion of Participants who Discontinue due to Adverse Effects [Срок оценки: Up to Week 3]
Вторичные конечные точки (11)
  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score [Срок оценки: Baseline, Week 3]
  • Change in Hamilton Depression Rating Scale (HDRS-17) Score [Срок оценки: Baseline, Week 3]
  • Change in Patient Health Questionnaire (PHQ-9) Score [Срок оценки: Baseline, Week 3]
  • Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score [Срок оценки: Baseline, Week 3]
  • Change in Work and Social Adjustment Scale (WSAS) Score [Срок оценки: Baseline, Week 3]
  • Change in Generalized Anxiety Disorder (GAD-7) Score [Срок оценки: Baseline, Week 3]
  • Post-Study System Usability Questionnaire (PSSUQ) Score [Срок оценки: Week 3]
  • System Usability Scale (SUS) Score [Срок оценки: Week 3]
  • Net Promoter Score (NPS) [Срок оценки: Week 3]
  • Brief Blinding Questionnaire (BBQ) Score [Срок оценки: Week 3]
  • Adverse Events [Срок оценки: Week 3]

Критерии участия

Критерии включения

  • Age between 24 and 65 years (inclusive)\*.
  • Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview.
  • Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening.
  • On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening.
  • No evidence of premorbid cognitive impairment, as demonstrated by a standard score >85 on the WRAT-5 Reading Recognition Subtest.
  • Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms.
  • Able to provide informed consent and comply with study procedures.
  • Access to a quiet space suitable for home-based light stimulation sessions.
  • English speaking: All study materials and assessments are only validated in English

Критерии исключения

  • Presence of primary neurological or autoimmune disorders.
  • Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder).
  • Current or recent diagnosis of alcohol or substance use disorder.
  • History of bipolar disorder or any psychotic disorder.
  • Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • History of seizure disorder or epilepsy.
  • History of migraine, tinnitus, or photosensitivity.
  • Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure.
  • Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).
  • Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT07111390 · 25-00522

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗