Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
Healthy Volunteers
ID06913309

Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder in China: a Randomised Controlled Trial

Led by Peking University Sixth Hospital · Updated on 2026-04-21

168

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

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 6:30 and 10:00 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

Who Can Participate

Age: 13Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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)

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 3 locations

1

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, China, 10000

Actively Recruiting

2

Peking University Sixth Hospital

Beijing, Beijing Municipality, China, 10000

Actively Recruiting

3

Yan'an Third People's Hospital

Yanan, Shanxi, China

Actively Recruiting

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Research Team

X

Xiaozhen Lv

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.

Ziru Zhao, Tianhang Zhou, Meimei Liu...

https://pubmed.ncbi.nlm.nih.gov/42150833