Unipolar Depression
Conditions
Keywords
Depression, Geriatrics, Psychiatry, Stress Disorders
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.
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).
Interventions
DEVICEBright 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
DEVICEdim 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study completion rate | Up to week 6 (Upon time of discharge from inpatient unit) | Percentage of patients who complete the study while psychiatrically hospitalized |
| Adequacy of allocation blinding | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | HAMD-17 is a commonly used clinician rating scale for depressive symptoms |
| Preliminary efficacy data - Mean change in Beck Depression Inventory II (BDI-II) Score | Day of enrollment, week 1, week 2, week 4, week 6 | BDI-II is a commonly used self-report rating scale for depressive symptoms |
Countries
United States
Outcome results
None listed