Home-based bright light therapy for adolescents with major depressive disorder

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

This trial will test whether home-based bright light therapy helps adolescents aged 13–17 with major depressive disorder improve mood and emotional and cognitive function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 13 Years to 17 Years
• Sex: All
• Sponsor: Peking University Sixth Hospital (Academic / other)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06913309 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled trial comparing high-intensity bright light, low-intensity bright light, and a dim red light placebo in outpatient adolescents with major depressive disorder. Eligible participants are 13–17 years old, medication-naïve or on a stable medication regimen for at least one week, and meet DSM-IV criteria for a major depressive episode confirmed by the MINI-Kid. Primary outcomes include clinical efficacy, time to onset of effect, safety, and applicability of home-based administration, with secondary analyses exploring neural mechanisms underlying changes in emotion and cognition. Participants will be recruited at three hospitals in China and will complete scheduled in-person assessments alongside the home-based light interventions.

Who should consider this trial

Good fit: Ideal candidates are 13–17-year-olds with DSM-IV major depressive episode and HAMD-17 score ≥14 who are medication-naïve or on a stable medication regimen for at least one week and can provide consent with their guardian.

Not a fit: Patients with primary psychiatric diagnoses other than anxiety or sleep disorders, or with a history of substance abuse or dependence, are unlikely to qualify or derive benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could provide a safe, nonpharmacologic, home-based treatment that reduces depressive symptoms and speeds recovery in adolescents.

How similar studies have performed: Bright light therapy is an established, effective treatment for seasonal affective disorder and has shown efficacy in adults with major depression, but its use in adolescents remains largely untested.

Eligibility criteria

The inclusion and exclusion criteria for MDD patients：

1. 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.
2. 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

1. 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.
2. 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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Beijing Huilongguan Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Sixth Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Yan'an Third People's Hospital — Yanan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Xiaozhen Lv

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