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Unipolar DepressionPhase 2NCT07002554

Bright Light Therapy for Depressed Geriatric Inpatients

A Phase 2 study testing Bright light therapy and dim red light in people with Unipolar Depression, run by Medical University of South Carolina at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Unipolar Depression
What is being tested?
Bright light therapy and dim red light
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
14 Nov 2025to 31 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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during study participation such that the treatment team feels ECT would be in their best interest, they will be withdrawn from study participation.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
Show all 10Show fewer
  • Severe intellectual disability
  • Inability to consent for the study
  • Active psychosis
  • Inmates

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Medical University of South Carolina Institute of Psychiatry Senior Care Unit

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: The LIGHT-60 Trial - Light Intervention for Geriatric Patients Hospitalized for Depression Treatment

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.

Read the detailed description

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).

Being tested
Bright light therapy, dim red light
Keywords
Depression, Geriatrics, Psychiatry, Stress Disorders
Medical subject headings
Depressive Disorder, Depression, Stress Disorders, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bright light therapyDevice

    Also called 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 lightDevice

    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.

Study groups in NCT07002554
Study groupRoleWhat they receive
Bright light therapyExperimentalParticipants 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.
Receives: Device: Bright light therapy
Dim Red lightSham comparatorParticipants 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.
Receives: Device: dim red light

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study completion rate

    Percentage of patients who complete the study while psychiatrically hospitalized

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

  2. 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

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

Secondary outcomes (2)

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

    HAMD-17 is a commonly used clinician rating scale for depressive symptoms

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

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

    BDI-II is a commonly used self-report rating scale for depressive symptoms

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start14 Nov 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002554
Sponsor's protocol ID
Pro00139703
Other IDs
R25DA020537
Status last verified
Apr 2026
First submitted
6 May 2025
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29500957

  • 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.

    PubMed 31600678

  • 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.

    PubMed 24397276

  • 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.

    PubMed 39067131

  • 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.

    PubMed 39356500

  • 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.

    PubMed 28969438

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bright light therapy and dim red light in people with Unipolar Depression, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study completion rate (time frame: Up to week 6 (Upon time of discharge from inpatient unit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002554, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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