Clinical Research Directory
Browse clinical research sites, groups, and studies.
The Efficacy and Feasibility of Bright Light Therapy in Adolescents With Depressive Disorder
Sponsor: Peking University Sixth Hospital
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 aged 10 to 19 years. Bright light therapy has been established as an effective treatment for seasonal affective disorder and has demonstrated considerable efficacy in adult patients with major depressive disorder. However, its application in adolescent patients with major depressive disorder remains largely unexplored. The aim of this clinical trial is to evaluate the efficacy and feasibility of bright light therapy in adolescents with major depressive disorder and to explore the potential neural mechanisms by which bright light therapy 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 major depressive disorder will be randomly assigned to one of three groups: a high-intensity bright light intervention group, a low-intensity bright light intervention group, and a control group receiving dark red light. Each group will undergo four weeks of light exposure, six days per week, for 40 minutes daily between 7:00 and 9:30 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. Additionally, the study will include healthy adolescent controls and collect functional Near-Infrared Spectroscopy (fNIRS) data from both the adolescent participants with major depressive disorder and the healthy controls at baseline. The fNIRS data will also be collected from the adolescent participants with major depressive disorder at the end of the intervention, in order to investigate the potential neural mechanisms by which light therapy alleviates depressive symptoms in adolescents.
Official title: The Efficacy and Feasibility of Bright Light Therapy in Adolescents With Depressive Disorder: a Multi-center Randomized Controlled Double-blind Study
Key Details
Gender
All
Age Range
13 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-04-01
Completion Date
2027-12-31
Last Updated
2025-04-06
Healthy Volunteers
Yes
Conditions
Interventions
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 plan is to receive 40 minutes of light therapy from 7:00-9:30 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）
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 7:00-9:30 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
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 7:00-9:30 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.