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

NCT06748716 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-12-27

No results posted yet for this study

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

Interventions

DEVICE

Blue-blocking glasses

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

DEVICE

Clear glasses

Clear-lensed glasses are placebo

Sponsors & Collaborators

  • Rayan NASSERDINE

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-04-01
Completion
2028-04-01

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748716 on ClinicalTrials.gov