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

NCT06748716 | Not Yet Recruiting

• 1 other identifier: PRD 17-2024-II
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar; Manic; Bipolar Disorder (BD); Dark Therapy; Actigraphy; Mania; RCT; Virtual Darkness

Outcome Measures

Primary Outcomes (1)

• 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).

  from baseline to day 10

Secondary Outcomes (5)

• Sleep quality

  from baseline to day 10

• Psychotics symptoms

  from baseline to day 10

• Kinectics of the decrease of manics symptoms

  from baseline to day 10

• Impact on maximal administred antipsychotic medication dosage

  from baseline to day 10

• Measure of the motor activity

  from baseline to day 10

Other Outcomes (2)

• Depressive symptoms

  from baseline to day 10

• Side effects

  from baseline to day 10

Study Arms (2)

Clear glasses

PLACEBO COMPARATOR

Device: Clear glasses

Orange glasses

EXPERIMENTAL

Intervention group

Device: Blue-blocking glasses

Interventions

Blue-blocking glasses DEVICE

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

Orange glasses

Clear glasses DEVICE

Clear-lensed glasses are placebo

Clear glasses

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rayan NASSERDINE: lead

Study Sites (1)

Hopitaux Universitaires de Genève

Geneva, Suisse, 1225, Switzerland

Location

MeSH Terms

Conditions

Mania; Bipolar Disorder

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated investigator, Medical Doctor, Clinical chef in HUG, Department of psychiatry

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 27, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)