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Enrolling by Invitation

NCT Number: NCT07002554

Bright Light Therapy for Depressed Geriatric Inpatients

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.

Enrolling by Invitation

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina Institute of Psychiatry Senior Care Unit

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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during study participation such that the treatment team feels ECT would be in their best interest, they will be withdrawn from study participation.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

Treatment and study plan

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

Other names: 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.

Primary outcomes

  1. Study completion rate

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

    Percentage of patients who complete the study while psychiatrically hospitalized

  2. Adequacy of allocation blinding

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

    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

Secondary outcomes

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

    Time frame: Day of enrollment, week 1, week 2, week 4, week 6

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

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

    Time frame: Day of enrollment, week 1, week 2, week 4, week 6

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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