Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder

NCT06913309 | Recruiting

• 1 other identifier: BRWEP2024W074110106
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief Summary

Major Depressive Disorder (MDD) is a chronic disease characterized by a high prevalence, low cure rate, and significant disability. Globally, depression is recognized as the leading cause of illness and disability among children and adolescents. Bright light therapy (BLT) has been established as an effective treatment for seasonal affective disorder and has demonstrated considerable efficacy in adult patients with MDD. However, its application in adolescent patients with MDD remains largely unexplored. The aim of this clinical trial is to evaluate the clinical efficacy, onset time, safety, and applicability of BLT in adolescents with MDD and to explore the potential neural mechanisms by which BLT enhances emotional and cognitive function in this population. This is a multicenter, randomized, controlled, double-blind study. It will involve adolescents aged 13 to 17 who are either untreated or have been stable on medication for at least one week. Adolescents with MDD will be randomly assigned to one of three groups: a high-intensity bright white light intervention group, a medium-intensity bright white light intervention group, and a placebo control group receiving dim red light. Each group will undergo four weeks of light exposure, six days per week, for 40 minutes daily between 6:30 and 10:00 AM. During the light exposure period, follow-up assessments will be conducted every weekend, and participants will be followed for two weeks after the completion of light exposure.The primary outcome will be the change in total scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline to week 4. Secondary outcomes will include response and remission rates, time to onset, maintenance of efficacy, self-reported depressive symptoms, sleep quality, cognitive function, anxiety, irritability, suicidal ideation, non-suicidal self-injury, self-efficacy, and the overall safety profile of BLT. Additionally, the study will include healthy adolescent controls and collect functional Near-Infrared Spectroscopy (fNIRS) from both the adolescent participants with major depressive disorder and the healthy controls at baseline. The fNIRS and MRI data will also be collected from the adolescent participants with MDD at the end of the intervention, in order to investigate the potential neural mechanisms by which light therapy alleviates depressive symptoms in adolescents.

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder，Major; Bright Light Therapy; Adolescent; Neural Mechanisms; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale-17(HAMD-17)

  The HAMD-17, developed by Hamilton in 1960, remains one of the most authoritative and widely utilized clinician-rated instruments for assessing depressive severity41. The Chinese version of the HAMD-17 has demonstrated satisfactory internal consistency (Cronbach's alpha = 0.714) and robust concurrent validity. The HAMD-17 assessment comprises 17 items; items 8, 9, and 11 are scored through structured behavioural observation, while the remaining items are primarily assessed via patient self-report during semi-structured interviews. Scoring utilized a five-point Likert scale for the majority of items (1-7, 10, 12-17), with exceptions employing a three-point scale for items 4-6 and 16. Total scores are derived from the summation of all item scores, with higher values indicating greater depressive severity.

  baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished

Secondary Outcomes (20)

• Generalized Anxiety Disorder-7(GAD-7)

  baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished

• Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR)

  baseline， every day of the first two weeks after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished

• Pittsburgh Sleep Quality Inventory (PSQI)

  baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished

• Hopkins Verbal Learning Test-Revised (HVLT-R)

  baseline, 14 days after the intervention begin, 28 days after the intervention begin，14 days after the intervention accomplished

• Brief Visuospatial Memory Test-Revised (BVMT-R)

  baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished

Study Arms (3)

Bright light therapy（Light intensity is 10,000lux）

EXPERIMENTAL

In this study, participants randomly assigned to the intervention group will receive bright white light therapy interventions with light intensities of 10000 lux. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 45cm from the light source.

Device: Bright light therapy（High light intensity）

Bright light therapy（Light intensity is 5,000lux）

EXPERIMENTAL

In this study, participants randomly assigned to the intervention group will receive bright white light therapy interventions with light intensities of 5000 lux. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

Device: Bright light therapy（Low light intensity）

Dim red light control intervention

PLACEBO COMPARATOR

In this study, participants randomly assigned to the placebo-controlled group will receive dim red light therapy interventions with light intensities of 100 lux. The placebo-controlled intervention plan is to receive 40 minutes of red light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

Device: Dim red light placebo-controlled intervention

Interventions

Bright light therapy（High light intensity） DEVICE

In this study, we will utilize the optocoupler-controllable light source, a product jointly developed by the School of Physics at Peking University and Peking University Sixth Hospital, which granted a national patent in China, for the purpose of intervention. Participants randomly assigned to the high light density intervention group will receive bright white light therapy interventions with light intensities of 10000 lux, and the main wavelength of light source is 476.4nm. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

Bright light therapy（Light intensity is 10,000lux）

Bright light therapy（Low light intensity） DEVICE

In this study, we will utilize the optocoupler-controllable light source, a product jointly developed by the School of Physics at Peking University and Peking University Sixth Hospital, which granted a national patent in China, for the purpose of intervention. Participants randomly assigned to the low light density intervention group will receive bright white light therapy interventions with light intensities of 5,000 lux,and the main wavelength of light source is 476.4nm. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

Bright light therapy（Light intensity is 5,000lux）

Dim red light placebo-controlled intervention DEVICE

In this study, participants randomly assigned to the placebo-controlled group will receive dim red light therapy interventions with light intensities of 100 lux, and the main wavelength of light source is 690.4nm. The placebo-controlled intervention plan is to receive 40 minutes of red light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

Dim red light control intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Meeting DSM-IV diagnostic criteria for a major depressive episode (first-episode or recurrent) , confirmed by two experienced, independent psychiatrists using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid);
• Aged 13-17 years ;
• Medication-naïve or on a stable pharmacological regimen for ≥1 week prior to enrollment;
• Baseline Hamilton Depression Rating Scale-17 (HAMD-17) score ≥14;
• Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;
• Voluntary participation with written informed consent provided by both participants and their legal guardians.
• Current or past diagnosis of psychiatric disorders other than anxiety or sleep disorders;
• History of substance abuse or dependence history (including alcohol, nicotine, or illicit drugs);
• Baseline Young Mania Rating Scale (YMRS) total score ≥6;
• Received or planned to initiate non-pharmacological systemic interventions within 6 months prior to enrollment or within 1 month after enrollment, including but not limited to: structured psychotherapy (≥1 session/month for \>6 months), physical therapy (e.g., modified electroconvulsive therapy \[MECT\], repetitive transcranial magnetic stimulation \[rTMS\], transcranial direct current stimulation \[tDCS\], or deep brain stimulation \[DBS\]), or exercise therapy ;
• Clinician-assessed suicide risk or a HAMD-17 item 3 score ≥3 at the baseline;
• Presence of severe systemic or neurological conditions, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;
• Severe retinal pathologies (e.g., retinal detachment, optic atrophy, macular degeneration); or having high myopia (spherical equivalent ≤ -6.00 diopters);
• Current use of photosensitizing agents or medications (e.g., chlorpromazine, hypericum extract);
• Any other condition deemed inappropriate by the investigators(e.g., cases involving severe sleep phase delays that make morning therapy impossible, or unrecorded photosensitivity).

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Study Sites (3)

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, 10000, China

RECRUITING

Peking University Sixth Hospital

Beijing, Beijing Municipality, 10000, China

RECRUITING

Yan'an Third People's Hospital

Yanan, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Xiaozhen Lv

CONTACT

+8601062723705; lxz120300@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available 6 to 12 months after the publication of the primary trial results and will remain accessible for up to 2 years (24 months).
• Access Criteria: Eligible Applicants: Access will be granted to qualified researchers who provide a methodologically sound research proposal and whose request has been approved by the study's Primary Investigators or an independent review committee. Purpose of Data Sharing: The data will be shared to facilitate the achievement of scientific objectives specified in the approved research proposal. Application Process and Workflow: Submission of Proposal: Interested applicants are required to submit a formal research proposal and a Statistical Analysis Plan (SAP) to the corresponding author via email at lvxiaozhen@bjmu.edu.cn. Review and Agreement: Upon approval of the proposal, the data requestor must sign a formal Data Access Agreement (DAA). this agreement ensures strict compliance with data security, ethical standards, and participant privacy protections.

Locations

CN (3)