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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lxz120300@163.com
• Phone: +8601062723705

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.