Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder
NCT ID: NCT06748716
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
96 participants
INTERVENTIONAL
2025-04-01
2028-04-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Clear glasses
Clear glasses
Clear-lensed glasses are placebo
Orange glasses
Intervention group
Blue-blocking glasses
The investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo.
Interventions
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Blue-blocking glasses
The investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo.
Clear glasses
Clear-lensed glasses are placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnostic of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
* aged 18-70 years
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Rayan NASSERDINE
OTHER
Responsible Party
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Rayan NASSERDINE
Associated investigator, Medical Doctor, Clinical chef in HUG, Department of psychiatry
Locations
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Hopitaux Universitaires de Genève
Geneva, Suisse, Switzerland
Countries
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Facility Contacts
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Hélène RICHARD-LEPOURIEL, MD, MSc, PD, head of unit
Role: primary
Rayan NASSERDINE, MD, clinical chef
Role: backup
Other Identifiers
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PRD 17-2024-II
Identifier Type: -
Identifier Source: org_study_id