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

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ClinicalTrials.gov Identifier: NCT03821506
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
Mental Health Services in the Capital Region, Denmark
Toyota-Fonden
Grosserer L. F. Foghts Fond Denmark
ELFORSK Danish Energy
Technical University of Denmark
Information provided by (Responsible Party):
Mental Health Centre Copenhagen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Dynamic Light Device: Usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinding of depression severity assessment
Primary Purpose: Treatment
Official Title: Dynamic LED-light Versus Usual Care for Depressed Inpatient: A Randomised Clinical Trial
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dynamic light
The experimental intervention is the installation of a dynamic LED-light system in 10 separate patient single rooms. The system includes three elements: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. All lamps will have a dynamic, time dependent frequency distribution and intensity of light.
Device: Dynamic Light
Dynamic Lighting system

Placebo Comparator: Usual care
The usual care is constant standard LED-light with two elements: two ceiling mounted lamps and a wall mounted lamp.
Device: Usual care
Standard lighting system




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale 6 item version [ Time Frame: Up to 3 weeks ]
    A scale, consisting of 7 items from the Hamilton depression Rating Scale, measuring severity of depression. Total scores from zero (no depression) to 24 (most severe depression)


Secondary Outcome Measures :
  1. Score on the SIDAS scale [ Time Frame: Up to 3 weeks ]
    Suicidal Ideation Attributes Scale (SIDAS). A scale measuring suicidal ideation. Total scores from zero (no suicidal ideation) to 50 (highest level of suicidal ideation).

  2. Hamilton Depression Rating Scale 17 item version [ Time Frame: Up to 3 weeks ]
    A Scale, consisting of 17 items of the Hamilton Depression Rating Scale, measuring severity of depression. Total scores from zero (no depression) to 52 (most severe depression)

  3. WHOQOL-BREF [ Time Frame: Up to 3 weeks ]
    Quality of life scale with four domains. Each scores is transformed to a zero (lowest quality of life) to 100 (highest quality of life) score.



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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A current episode of a major depressive episode (DSM-5) as part of a unipolar or bipolar disorder.
  • Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilizing treatment
  • Age > 18 years
  • Informed consent
  • Danish speaking.

Exclusion Criteria:

  • Severe suicidality
  • Abuse of alcohol and / or drugs
  • Actual psychotic state within last four weeks
  • Actual Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode
  • Patient is subject to coercive measures of any kind.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821506


Contacts
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Contact: Anne Sofie Aggestrup, MSc +4538647100 anne.sofie.aggestrup@regionh.dk
Contact: Carlo Volf, PhD +4538647022 carlo.volf@regionh.dk

Locations
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Denmark
Psychiatic Hospital Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Mental Health Centre Copenhagen
Mental Health Services in the Capital Region, Denmark
Toyota-Fonden
Grosserer L. F. Foghts Fond Denmark
ELFORSK Danish Energy
Technical University of Denmark
Investigators
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Study Director: Klaus Martiny, DMSc Psychiatic Hospital Copenhagen

Publications of Results:
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Responsible Party: Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT03821506     History of Changes
Other Study ID Numbers: Version 1.7
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms