Bright Light Therapy for Depressed Geriatric Inpatients

NCT ID: NCT07002554

Last Updated: 2025-12-12

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-14

Study Completion Date

2026-04-30

Brief Summary

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Bright light therapy has been shown to be effective for the treatment of both seasonal and non-seasonal unipolar depression as well as bipolar depression, primarily in outpatients under the age of 60. There is a dearth of studies exploring the efficacy of this treatment modality among elderly depressed inpatients, which is our study population.

Detailed Description

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Investigators are studying the ability of light therapy to reduce depressive symptoms in elderly patients who are hospitalized with unipolar depression (depression that is not due to bipolar disorder). Participants will receive either active light treatment or inactive treatment (also known as placebo).

Conditions

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Unipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type EXPERIMENTAL

Bright light therapy

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

dim red light

Intervention Type DEVICE

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.

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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light therapy

Eligibility Criteria

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Inclusion Criteria

* A current episode of non-psychotic unipolar depression as the primary reason for psychiatric hospitalization
* Currently hospitalized on the MUSC Senior Care Unit
* Age 60 years or older
* HAMD-17 ≥8

Exclusion Criteria

* Any prior use of bright light therapy
* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Kalivas

Associate Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 24397276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29500957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31600678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39067131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39356500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28969438 (View on PubMed)

Other Identifiers

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R25DA020537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00139703

Identifier Type: -

Identifier Source: org_study_id

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