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.
None
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;
Parallel
Bright light therapy（High light intensity）
DeviceIn 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（Low light intensity）
DeviceIn 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.
Dim red light placebo-controlled intervention
DeviceIn 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.
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.
Generalized Anxiety Disorder-7(GAD-7)
The GAD-7, developed by Spitzer et al. in 2006, is a brief self-administered screening questionnaire evaluating the severity of anxiety symptoms. It consists of 7 items rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores reflecting greater anxiety severity. The Chinese version of the GAD-7 has demonstrated excellent psychometric properties, exhibiting robust internal consistency (Cronbach's α = 0.93-0.95) among large Chinese adolescent cohorts.
Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR)
The QIDS-SR, first developed and validated by Rush and colleagues in 2003, is a DSM-IV-based self-report tool specifically designed to assess depressive symptomatology over a seven-day recall period42. The QIDS-SR16 has been validated as a reliable and effective instrument for adolescent outpatients, demonstrating high internal consistency and a robust unidimensional structure. It comprises 16 items, each rated on a 0-3 point scale, with higher total scores indicating greater severity of depressive symptoms. In this study, the QIDS-SR was used to assess self-reported depressive symptoms.
Pittsburgh Sleep Quality Inventory (PSQI)
The PSQI, developed by Buysse et al. in 1989 at the University of Pittsburgh, is a self-rated questionnaire designed to assess sleep quality. The Chinese version of the PSQI, validated by Liu et al., demonstrated high internal consistency with a Cronbach's alpha of 0.84 and excellent test-retest reliability with an r value of 0.81 over a two-week period. It comprises nine items: the first four are open-ended, and the remaining five are multiple-choice, with Item 5 containing ten sub-items. These items collectively evaluate seven sleep components, each scored 0-3, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Hopkins Verbal Learning Test-Revised (HVLT-R)
HVLT-R is a widely used neuropsychological assessment tool designed to evaluate verbal memory and cognitive function. Developed by J. Brandt and Benedict in 2001, the HVLT-R consists of a list of 12 nouns divided into three semantic categories (e.g., dwelling places, four-legged animals, and precious stones), with four words per category. The assessment involves three learning trials, where participants are presented with the list of words and are asked to recall as many words as possible immediately after each presentation. Additionally, there is a delayed recall trial, where participants are asked to recall the words after a delay of 20-25 minutes. The scoring principle is based on the number of correctly recalled words during each learning trial and the delayed recall trial. The total scores of the three learning trials and the delayed recall trial were computed to represent verbal learning and memory function.
Click on the lead sponsor to view all of their trials.
