About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Blue-blocking glasses
- Clear glasses
Treatment groups
Sponsors and collaborators
Rayan NASSERDINE
Lead sponsor
University Hospital, Geneva
Sponsor institution