Bright Light Therapy for Depressed Geriatric Inpatients
NCT ID: NCT07002554
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
20 participants
INTERVENTIONAL
2025-11-14
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bright light therapy
Participants in the intervention group will receive bright light therapy (BLT) consisting of 10,000 lux of bright white light administered for 30 minutes each morning, ideally within 30 minutes of awakening. Participants in both arms will continue to receive other treatment as usual (group therapy and medication management) as deemed appropriate by their treating clinicians.
Bright light therapy
the Verilux® HappyLight® Lumi Plus light therapy box, which delivers UV-free, full-spectrum LED light at an intensity of 10,000 lux
Dim Red light
Participants in the control group will receive a placebo condition using an identical light box fitted with a translucent red screen to emit dim red light at an intensity of less than 2,500 lux, which lacks efficacy for depression treatment based on prior research. Participants in both arms will continue to receive other treatment as usual (group therapy and medication management) as deemed appropriate by their treating clinicians.
dim red light
The control group will use the same light box device, configured to emit dim red light. This will be achieved by setting the box to its lowest brightness setting and overlaying a translucent red filter over the light display. This setup is intended to maintain the appearance and experience of light exposure while minimizing any therapeutic effect.
Interventions
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dim red light
The control group will use the same light box device, configured to emit dim red light. This will be achieved by setting the box to its lowest brightness setting and overlaying a translucent red filter over the light display. This setup is intended to maintain the appearance and experience of light exposure while minimizing any therapeutic effect.
Bright light therapy
the Verilux® HappyLight® Lumi Plus light therapy box, which delivers UV-free, full-spectrum LED light at an intensity of 10,000 lux
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently hospitalized on the MUSC Senior Care Unit
* Age 60 years or older
* HAMD-17 ≥8
Exclusion Criteria
* Primary indication for hospitalization is for a disorder other than major depressive disorder (determined by patient's treatment team)
* Photosensitive medical conditions or current use of photosensitizing medications - if patients have been advised by a treating clinician at any point to avoid sunlight because of their current medication regimen or medical condition, they will be considered to have a photosensitive medical condition and will be excluded from this study.
* Treatment with ECT; if a patient's condition deteriorates during study participation such that the treatment team feels ECT would be in their best interest, they will be withdrawn from study participation. For logistical and transport purposes, the study team feels that exclusion of patients receiving ECT will be necessarily. Additionally, these patients would likely be excluded from a future larger RCT given that ECT would likely interfere with signal of BLT efficacy.
* Uncontrolled headaches or any migraines within the last month
* Major neurocognitive disorder
* Severe intellectual disability
* Inability to consent for the study
* Active psychosis
* Inmates
60 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Benjamin Kalivas
Associate Professor-Faculty
Principal Investigators
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Rindy Fernandes, DO
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina Institute of Psychiatry Senior Care Unit
Charleston, South Carolina, United States
Countries
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References
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Oldham MA, Ciraulo DA. Bright light therapy for depression: a review of its effects on chronobiology and the autonomic nervous system. Chronobiol Int. 2014 Apr;31(3):305-19. doi: 10.3109/07420528.2013.833935. Epub 2014 Jan 7.
Zhao X, Ma J, Wu S, Chi I, Bai Z. Light therapy for older patients with non-seasonal depression: A systematic review and meta-analysis. J Affect Disord. 2018 May;232:291-299. doi: 10.1016/j.jad.2018.02.041. Epub 2018 Feb 17.
Geoffroy PA, Schroder CM, Reynaud E, Bourgin P. Efficacy of light therapy versus antidepressant drugs, and of the combination versus monotherapy, in major depressive episodes: A systematic review and meta-analysis. Sleep Med Rev. 2019 Dec;48:101213. doi: 10.1016/j.smrv.2019.101213. Epub 2019 Sep 18.
Tong H, Dong N, Lam CLM, Lee TMC. The effect of bright light therapy on major depressive disorder: A systematic review and meta-analysis of randomised controlled trials. Asian J Psychiatr. 2024 Sep;99:104149. doi: 10.1016/j.ajp.2024.104149. Epub 2024 Jul 15.
Menegaz de Almeida A, Aquino de Moraes FC, Cavalcanti Souza ME, Cavalcanti Orestes Cardoso JH, Tamashiro F, Miranda C, Fernandes L, Kreuz M, Alves Kelly F. Bright Light Therapy for Nonseasonal Depressive Disorders: A Systematic Review and Meta-Analysis. JAMA Psychiatry. 2025 Jan 1;82(1):38-46. doi: 10.1001/jamapsychiatry.2024.2871.
Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.
Other Identifiers
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Pro00139703
Identifier Type: -
Identifier Source: org_study_id
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