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

Official title

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

Overview

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.

Interventions

• Device Bright light therapy（High light intensity）
  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 pl
• Device Bright light therapy（Low light intensity）
  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
• Device Dim red light placebo-controlled intervention
  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.

Primary outcome measures

• Hamilton Depression Rating Scale-17(HAMD-17) [Time frame: 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 outcome measures (12)

• Generalized Anxiety Disorder-7(GAD-7) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished]
• Color Trails Test (CTT) [Time frame: baseline，14 days after the intervention begin，28 days after the intervention begin，14 days after the intervention accomplished]
• The General Self-Efficacy Scale (GSES) [Time frame: 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]
• Young Mania Rating Scale (YMRS) [Time frame: 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]
• Asberg Side-Effect Rating Scale for Antidepressants(SERS) [Time frame: 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]
• Adolescent Irritability Rating Scale (ARI) [Time frame: 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]
• Stroop Color-Word Test (SCWT) [Time frame: baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished]
• Ottawa Self-Injury Inventory (OSI) [Time frame: 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]

Eligibility criteria

The inclusion and exclusion criteria for MDD patients：

• inclusion criteria

• 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.
• exclusion criteria

• 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).

The inclusion and exclusion criteria for Health controls

• Inclusion criteria

• Aged 13-17 years and right-handed;
• 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.
• Exclusion criteria

• Current or lifetime diagnosis of any psychiatric disorders (e.g., schizophrenia, mood disorders, anxiety disorders) or history of substance/drug abuse or dependence;
• First-degree family history of psychiatric disorders;
• Presence of severe systemic or neurological disorders, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;
• Any other condition deemed inappropriate by the investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 3 centers

• Beijing Huilongguan Hospital — Beijing
• Peking University Sixth Hospital — Beijing
• Yan'an Third People's Hospital — Yanan

Publications

• Zhao Z, Zhou T, Liu M, Wang N, Li Y, Yang C, Qiu Y, Wang J, Wu W, Bai Y, Su Y, He Y, Zhang Y, Chen L, Shi Z, Xie T, Wang J, Yuan J, Dang W, Dong W, Chen Z, Yu X, Lv X. 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. BMJ Open. 2026 May 18;16(5):e113503. doi: PMID 42150833

Identifiers

NCT: NCT06913309 · BRWEP2024W074110106

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗