Evaluating Home-Based Bright Light Therapy for Adolescents Aged 13 to 17 With Major Depressive Disorder in China A Randomized Controlled Study
Led by Peking University Sixth Hospital · Updated on 2026-04-21
168
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Major Depressive Disorder MDD is a chronic condition causing significant illness and disability, especially among children and adolescents worldwide. This trial studies the use of bright light therapy BLT in adolescents aged 13 to 17 with MDD, aiming to evaluate its effectiveness, speed of improvement, safety, and how it may improve emotional and cognitive functions. The research also explores the brain mechanisms involved in these effects using imaging techniques.
Participants with MDD will be randomly assigned to one of three groups high-intensity bright white light therapy 10,000 lux, medium-intensity bright white light therapy 5,000 lux, or a placebo group receiving dim red light 100 lux. Each participant will undergo 40 minutes of light exposure between 630 and 1000 AM, six days a week, for four consecutive weeks. Healthy adolescent controls will also be included for comparison and brain imaging studies.
During the study, participants will be assessed weekly during the light therapy period and followed for two weeks afterward. Assessments include depression severity using the Hamilton Depression Rating Scale, anxiety, sleep quality, cognitive function, irritability, self-injury behaviors, and safety monitoring. Advanced brain imaging using functional Near-Infrared Spectroscopy fNIRS and MRI will be conducted to investigate the neural effects of light therapy. This study aims to provide comprehensive data on the benefits and mechanisms of BLT in adolescent depression.
CONDITIONS
Brief Title
Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder
Research Team
X
Xiaozhen Lv
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Diagnosis of major depressive episode confirmed by two psychiatrists using the Mini International Neuropsychiatric Interview for Children and Adolescents
Aged between 13 and 17 years
Medication-naive or stable on medication for at least 1 week before enrollment
Baseline Hamilton Depression Rating Scale-17 (HAMD-17) score of 14 or higher
At least 5 years of formal education and able to complete assessments and understand study information
Voluntary participation with written informed consent from participant and legal guardians
You will not qualify if you...
Current or past psychiatric disorders other than anxiety or sleep disorders
History of substance abuse or dependence including alcohol, nicotine, or illicit drugs
Baseline Young Mania Rating Scale (YMRS) score of 6 or higher
Received or planned to receive non-pharmacological systemic interventions within 6 months before or 1 month after enrollment
Clinician-assessed suicide risk or HAMD-17 item 3 score of 3 or higher at baseline
Severe systemic or neurological diseases such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy
Severe retinal diseases or high myopia (spherical equivalent ≤ -6.00 diopters)
Current use of photosensitizing medications
Any other condition judged inappropriate by investigators (e.g., severe sleep phase delays or unrecorded photosensitivity)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive home-based bright light therapy or dim red light placebo therapy daily in the morning for 40 minutes, 6 days a week, over 4 consecutive weeks.
Daily sessions, 6 days per week for 4 weeks
Follow-up
Duration - 2 weeks
Participants are monitored for outcomes and safety for 2 weeks after the treatment ends.
Visits at 7 and 14 days after treatment completion
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Clinical efficacy, safety and applicability of home-based bright light therapy in outpatient adolescents with major depressive disorder in China: protocol for a randomised controlled trial.