NCT03821506

ROOM-LIGHT: Effect of a Dynamic Lighting System in Depressed Inpatients

Completed NA Last updated 25 February 2026

What this trial tests

NA trial testing Dynamic Light in Major Depressive Disorder in 60 participants. Completed in 15 March 2023.

Timeline

15 May 2019

Primary endpoint
15 March 2023

15 March 2023

Quick facts

Lead sponsor	University Hospital Bispebjerg and Frederiksberg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	15 May 2019
Primary completion	15 March 2023
Estimated completion	15 March 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Dynamic Light
• Usual care

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

University Hospital Bispebjerg and Frederiksberg

Who can join

17 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: despite developments a substantial part of patients with depression will only recover slowly. Light therapy from light boxes has shown antidepressant effects but have several limitations: time consuming, only allowing a fixed spectral distribution, only delivered at a specific time-point, and often with inadequate light intensity delivered at the retina. Therefore, we developed a new dynamic lighting system using light fixtures that are built into the room and can change intensity and spectral distribution of light during the 24-hour day.

Objectives: the objective of this trial is to assess the beneficial and harmful effects of a newly developed dynamic lighting system using Light Emitting Diodes (LED) -light armatures aiming to mimic sunlight, when installed in the patient rooms of a psychiatric inpatient ward, compared with usual care.

Design: the design is a randomised controlled trial with two arms: an active dynamic light trial arm and a usual care arm with blinding of depression outcome, and data analyses. Randomisation will be 1:1.

Inclusion criteria: a current episode of a major depressive episode as part of a unipolar or bipolar disorder. Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilising treatment, age \> 18 years, informed consent.

Exclusion criteria: severe suicidality, abuse of alcohol and / or drugs, actual psychotic state, Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode.

Interventions: the experimental intervention is a dynamic LED-light system in 10 separate patient single rooms with three dynamic lamps: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. The usual care is constant standard LED-light.

Primary outcome: score on the Hamilton Depression Rating Scale 6 item version (HAM-D6) scale at week 3

Secondary outcomes: score on the Suicidal Ideation Attribution Scale (SIDAS ) scale at week 3, and score in the Hamilton. Depression Rating Scale 17 item version (HAM-D17) scale at week 3, and score on the World Health Organisation Quality Of Life questionaire abbreviated version (WHOQOL-BREF) at week 3.

Trial size: in total, 150 patients.

Time schedule: the trial will be submitted for regulatory approvals January 2019, the first participant will be included April 2019, the expected last follow-up of the last participant will be December 2020, the expected last follow-up after 6 months will be June 2021, data will be analysed from June 2021 till September 2021, manuscripts will be prepared from December 2020, and we expect to submit first manuscript December 2021.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.
   Volf C, Aggestrup AS, Petersen PM, Dam-Hansen C, et al · · 2020 · cited 3× · PMID 31988225 · DOI 10.1136/bmjopen-2019-032233