Tests blue-blocking glasses for manic symptoms in bipolar disorder
Tests orange blue-blocking glasses against clear glasses in adults with bipolar disorder during mania.
Plain-language title generated from the registry record
Registry title: Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder
Key facts
- Where
- Geneva, SwitzerlandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06748716, who can take part
Where in Switzerland
- Hôpitaux universitaires de GenèveGeneva, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rayan NASSERDINE
- Trial code
- NCT06748716
- Record updated
- 27 December 2024
- Original description
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.Read full original descriptionShow less
Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder: a Randomized Placebo-controlled Trial BLUME (Blue Light Filtering in Manic Episodes)
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.
Inclusion: 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.
Exclusion: previous knowledge of blue-blocking glasses; 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); severe eye disease or traumatic injury affecting both eyes; not consenting to participate.