The Efficacy and Feasibility of Bright Light Therapy in Adolescents With Depressive Disorder

Last updated: March 30, 2025
Sponsor: Peking University Sixth Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Treatment

Bright light therapy(High light intensity)

Bright light therapy(Low light intensity)

Dim red light placebo-controlled intervention

Clinical Study ID

NCT06913309
BRWEP2024W074110106
  • Ages 13-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

  1. Adolescents with Major Depressive Disorder Inclusion Criteria:all of the following conditions were met for inclusion:
  • Meet the diagnostic criteria for depressive episodes in the Diagnostic andStatistical Manual of Mental Disorders (DSM-V) (either first or recurrent), andbe clearly diagnosed by two physicians using MINI-kid 2.0;
  • Age 13 to 17 years, right-handed, and gender-neutral; ③Not currently onmedication; or have been stabilized on the original medication regimen forat least 1 week; ④ Hamilton Depression Scale (HAMD-17) score ≥14 atbaseline; ⑤ Years of education ≥ 5 years and can cooperate in completingthe scale assessment;
  • Subjects volunteered to participate in the study, and both subjectsand guardians signed an informed consent form.

Exclusion

Exclusion Criteria: excluded if any of the following conditions are met:

  • A history of previous or current episodes of other psychiatric disorders, suchas (schizophrenia, autism spectrum disorders, and schizoaffective disorders,etc.);
  • Previous history of drug or substance abuse or dependence;
  • Total score of ≥ 8 on the Young's Mania Scale as assessed by theinvestigator for the subject; ④ Have received, or are currently receiving, or have planned toreceive in the last month, other systemic interventions other thanmedication in the 6 months prior to enrollment, e.g., systemicpsychotherapy (1 to 2 times per month for more than 6 months),physical therapy other than phototherapy, or exercise therapy; ⑤ Those who are medically unstable, or unable to cooperate incompleting the study; those who are currently at serious risk ofsuicide as assessed by the investigator (HAMD-17 entry 3 score ≥ 3);
  • Comorbid serious physical illnesses such as severe liverfunction abnormalities, hyper/hypothyroidism and abnormalthyroid function, encephalitis, head trauma or coma, epilepsy,loss of consciousness, diabetes mellitus, renal failure, etc.;or those whose clinical laboratory findings at the time ofenrollment are, in the opinion of the investigator,significantly out of the reference range and of clinicalsignificance; ⑦ Comorbid visual pathway diseases (retinaldetachment, optic nerve atrophy, macular degeneration, etc.),systemic diseases that have an impact on the retina, high myopia (myopia of 600 degrees and above); or those who are usingphotosensitizers, drugs with potential photosensitizing effects (e.g., chlorpromazine, tricyclic antidepressant, chrysothema,etc.); ⑧ According to the opinion of the research group, thosewho are not suitable for other conditions of this study.
  1. Adolescent Health Controls Criteria for inclusion: All of the following conditions were met for inclusion:
  • Age 13-17 years old, right-handed, gender is not limited;
  • Years of education ≥ 5 years, can cooperate with the completion of thescale assessment; ③Subjects volunteered to participate in the study, andboth subjects and guardians signed an informed consent form. Exclusion Criteria: excluded if any of the following conditions are met:

①Previous or current suffering from any mental illness (e.g., schizophrenia,loneliness spectrum disorders, anxiety disorders and schizoaffective disorders,etc.), or a history of drug or substance abuse or dependence;

② First-degree relatives with a family history of mental illness;

③Comorbid serious physical illnesses such as severe liver function abnormalities,hyper/hypothyroidism and thyroid function abnormalities, encephalitis, head traumaor coma, epilepsy, loss of consciousness, diabetes mellitus, renal failure, etc.; orthose whose clinical laboratory findings at the time of enrollment were consideredby the investigator to be significantly out of the reference range and of clinicalsignificance;

④ Those with other conditions that, according to the opinion of the study group, arenot suitable for this study.

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Bright light therapy(High light intensity)
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
December 31, 2027