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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Blue-blocking glasses
DeviceThe investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo.
Clear glasses
DeviceClear-lensed glasses are placebo
Treatment groups
Trial outcomes
Primary outcomes
Manics symptoms
The primary endpoint will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. The YMRS is a checklist of 11 items that are ranked on a scale of 0-4 or 0-8, the latter anchoring given to the four items which can be rated even with patients with poor cooperation. The score range therefore is between 0 and 60. This scale is classically used to assess the effectiveness of the treatment on manic symptoms. This is a clinical interview scale to assess the severity of manic states primarily used for research and it is designed to measure the severity of manic states, it can help guide clinicians on treatment planning and progress. The investigators define a score of at least 20 points on the YMRS (\> 20) to identify a manic state and the lower the score, the more the patient is in a state of euthymia (scale \<2).
Secondary outcomes
Sleep quality
The investigators aim to assess the sleep quality for each participant by the Pittsburgh Sleep Quality Index (PSQI) and hypothesize that the patients receiving the intervention will have a better sleep quality. The scale assesses a broad range of sleep domains and consists of 19 self-rated questions that measure seven components of sleep that are scored from 0 to 3: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction. The global score is the combination of the seven sub-scores and ranges therefore from 0 to 21, with higher scores for worse sleep quality; the cut-off point to define "poor sleepers" is \>5.
Psychotics symptoms
The investigators aim to assess the presence or absence of psychotics symptoms by the Positive and Negative Syndrome Scale (PANSS). The scale has mostly been used to inventory, grade and follow the symptoms in schizophrenia. It quantifies positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions. The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112
Kinectics of the decrease of manics symptoms
The investigators aim to assess the kinetics of the decrease of manics symptoms for each participtant and hypothesize that participants receiving the intervention will have a faster decrease in the Young Mania Rating Scale (YMRS).
Impact on maximal administred antipsychotic medication dosage
The investigators aim to record the dosage of antipsychotic treatment for each patient and hypothesize that participants receiving the intervention will have lower dosage.
Other outcomes
Depressive symptoms
The investigators aim to assess the incidence and severity of depressive symptoms (in manic episode) or aggravation of depressive symptoms (in manic episode with mixed features) by the Montgomery-Asberg Depression Rating Scale (MADRS). The rating should be based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones which allow a precise rating of severity. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60). This is our cut-offs : scores of 0-6 indicate an absence of symptoms; 7-19 represent mild depression; 20-34 moderate; 35-60 indicate severe depression.
Side effects
All adverse effects will be rigorously monitored during the whole study for each participant. Number of participants with treatment-related adverse events will be recorded if present.
Sponsors and contacts
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Rayan NASSERDINE
Lead sponsor
University Hospital, Geneva
Sponsor institution
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