Bright Light Therapy for Depressed Geriatric Inpatients

NCT07002554 | Enrolling By Invitation Phase 2

• 2 other identifiers: Pro00139703R25DA020537
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unipolar Depression

Keywords

Depression; Geriatrics; Psychiatry; Stress Disorders

Outcome Measures

Primary Outcomes (2)

• Study completion rate

  Percentage of patients who complete the study while psychiatrically hospitalized

  Up to week 6 (Upon time of discharge from inpatient unit)

• Adequacy of allocation blinding

  assessed by the proportion of participants who correctly identify their study arm allocation. Blinding will be considered adequate if the proportion of correct guesses does not significantly exceed chance levels

  Up to week 6 (Upon time of discharge from inpatient unit)

Secondary Outcomes (2)

• Preliminary efficacy data - Mean change in Hamilton Depression Rating Scale 17 item scale (HAMD-17)

  Day of enrollment, week 1, week 2, week 4, week 6

• Preliminary efficacy data - Mean change in Beck Depression Inventory II (BDI-II) Score

  Day of enrollment, week 1, week 2, week 4, week 6

Study Arms (2)

Bright light therapy

EXPERIMENTAL

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.

Device: Bright light therapy

Dim Red light

SHAM COMPARATOR

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.

Device: dim red light

Interventions

Bright light therapy DEVICE

the Verilux® HappyLight® Lumi Plus light therapy box, which delivers UV-free, full-spectrum LED light at an intensity of 10,000 lux

Also known as: light therapy

Bright light therapy

dim red light 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.

Dim Red light

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Uncontrolled headaches or any migraines within the last month
• Major neurocognitive disorder
• Severe intellectual disability
• Inability to consent for the study
• Active psychosis
• Inmates

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina Institute of Psychiatry Senior Care Unit

Charleston, South Carolina, 29425, United States

Location

Related Publications (6)

• 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.

  PMID: 29500957 BACKGROUND

• 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.

  PMID: 31600678 BACKGROUND

• 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.

  PMID: 24397276 BACKGROUND

• 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.

  PMID: 39067131 BACKGROUND

• 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.

  PMID: 39356500 BACKGROUND

• 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.

  PMID: 28969438 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder; Depression; Stress Disorders, Traumatic

Interventions

Ultraviolet Therapy; Phototherapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Rindy Fernandes, DO

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 3, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)