Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder

Официальное название

Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder: a Randomized Placebo-controlled Trial BLUME (Blue Light Filtering in Manic Episodes)

Обзор

This study will be a randomized controlled trial (RCT) measuring the efficacy of wearing blue-blocking glasses (orange glasses) on manic symptoms in a population of patients suffering from Bipolar Disorder (BD), hospitalized for a manic episode on 10 days compared to non-filtering glasses (clear glasses, placebo) in addition to pharmacological treatment as usual. The primary objective of this study is to evaluate the efficacity of orange glasses on improving manic symptoms in adult patients presenting BD in comparison with placebo. The primary outcome will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. Secondary objectives will be change in sleep quality, in motor activity (patterns of activity and rest), impact on psychotics symptoms, kinetics of the decrease of the manic symptoms from inclusion to the study and impact on maximal administered antipsychotic medication dosage ; they will be explored. The investigators hypothesize that orange glasses is more effective than placebo in improving manic symptoms as an adjuvant treatment. This project will take place in Alizé unit which is a newly conceived specialized ward dedicated to treating BD, at the HUG. The methodology has been developed in collaboration with the center of clinical research (CRC). The study will be conducted in accordance with established ethical and data management/protection practices.

Подробное описание

The design of the study is a monocentric, single-blinded, two-arm parallel-group randomized placebo-controlled trial in a newly developed specialized mood disorder ward at the Geneva University Hospitals. The methodological aspects of this trial are elaborated in consultation with the Centre of Clinical Research (CRC) of our Hospital. The adjunctive treatment consists in wearing BBG for a few hours between 7pm and bedtime for ten days. Orange glasses (intervention) are from Melamedic®, type UV530 (Medical Device Class I - 93/42 EEC made in Denmark).

The adjunctive treatment will be compared to a placebo (clear-lensed glasses), both groups will also receive an active treatment as usual (the standard of care for treating manic episode following Swiss and international guidelines). No treatments are prohibited. All pharmacological treatments will be recorded. Due to the particularity of the device, the clinicians and the patient cannot be blind to the treatment condition (orange glasses vs clear glasses) which is an acknowledged limitation. The participants were masked to group assignment by receiving identical limited information about the purpose of the study : testing the effectiveness of different types of glasses in reducing manic symptoms by blocking different wavelengths of light. Patients will be randomized after eligibility has been established and written consent has been sought. If the patient capacity to consent is impaired, legal representative will be informed and capacity to consent will be re-assessed before each visit to obtain a written consent (delayed consent). Signs showing that the participant is unwilling to participate in the study will result in the participant exclusion (explicit refusal). The expected total duration of participation is 10 days. Data will be analyzed in an intention-to-treat design.

Вмешательства

• Устройство Blue-blocking glasses
  The investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo.
• Устройство Clear glasses
  Clear-lensed glasses are placebo

Первичные конечные точки

• Manics symptoms [Срок оценки: from baseline to day 10]

Вторичные конечные точки (5)

• Sleep quality [Срок оценки: from baseline to day 10]
• Psychotics symptoms [Срок оценки: from baseline to day 10]
• Kinectics of the decrease of manics symptoms [Срок оценки: from baseline to day 10]
• Impact on maximal administred antipsychotic medication dosage [Срок оценки: from baseline to day 10]
• Measure of the motor activity [Срок оценки: from baseline to day 10]

Критерии участия

Критерии включения

• Patients hospitalized with manic symptoms in HUG
• Diagnostic of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
• aged 18-70 years

Критерии исключения

• previous knowledge of blue-blocking glasses
• not consenting to participate
• severe eye disease or traumatic injury affecting both eyes.
• withdrawal symptoms from any drug or alcohol at the time of admission (the start of the intervention will be delayed until withdrawal symptoms have ceased)

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Hopitaux Universitaires de Genève — Geneva

Идентификаторы

NCT: NCT06748716 · PRD 17-2024-II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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