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NOT YET RECRUITING
NCT06748716
NA

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

Sponsor: Rayan NASSERDINE

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2025-04-01

Completion Date

2028-04-01

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

DEVICE

Blue-blocking glasses

The investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo.

DEVICE

Clear glasses

Clear-lensed glasses are placebo

Locations (1)

Hopitaux Universitaires de Genève

Geneva, Suisse, Switzerland