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NCT Number: NCT06973759

Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness

This study examines the efficacy of bright light therapy as a treatment for adolescents diagnosed with unipolar non-seasonal depression who exhibit an evening chronotype.

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This randomized, placebo-controlled, assessor-blinded trial aims to evaluate the efficacy of bright light therapy (BLT) as a treatment for adolescents with depression and evening chronotype. Eligible participants will be randomized to receive either BLT or dim red light (placebo) daily for 8 weeks. Depression severity, sleep parameters, and circadian markers will be assessed at baseline, during treatment, post-treatment, and at follow-up visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese, aged 12-19 years old;
  • Written informed assent/consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18), respectively;
  • Having a DSM-5 diagnosis of unipolar non-seasonal depression as confirmed by the Chinese version of the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS) psychiatric interview, DSM-5 Seasonal specifier, AND having a score on Children's Depression Rating Scale (CDRS-R) at least 40;
  • Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. <12.

Exclusion criteria

  • A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, organic mental disorders, or intellectual disabilities;
  • Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;
  • Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
  • Initiation of or change in antidepressant medication within past 4 weeks;
  • Having been or is currently receiving any structured psychotherapy;
  • With hearing or speech deficit;
  • Night shift worker;
  • Trans-meridian flight across at least two time zones in the past 3 months and during the study;
  • Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.

Treatment and study plan

Bright Light Therapy

Device

Exposure to blue-enriched white light for 15-30 minutes a day for 8 weeks

Dim red light

Device

Exposure to dim red light for 15-30 minutes a day for 8 weeks.

Primary outcomes

  1. Change of depressive symptoms

    Time frame: Soon after the intervention

    Change in the score of the Children's Depression Rating Scale (CDRS-R), which ranges from 17-113, higher score indicates higher severity of depression.

Secondary outcomes

  1. Change of other clinical symptoms

    Time frame: Soon after the intervention

    Change in Beck Depression Inventory (BDI) score, which ranges from 0-63, higher score indicates greater depression severity.

  2. Change of other clinical symptoms

    Time frame: Soon after the intervention

    Change in Pittsburgh Sleep Quality Index (PSQI) score, which ranges from 0-21, higher score indicates poorer sleep quality.

  3. Change of other clinical symptoms

    Time frame: Soon after the intervention

    Change in Behavior Rating Inventory of Executive Function (BRIEF2) score, which will be transformed into T scores (range = 35 to ≥ 90) for interpretion, higher score indicates higher executive functioning.

  4. Change of other clinical symptoms

    Time frame: Soon after the intervention

    Change in KIDCSREEN-27 score, which ranges from 30-135, higher score indicates better life quality and social support.

Study contacts

Contact information is provided by the study sponsor or research team.

Joey WY Chan

CONTACT

[email protected]

+852 39197647

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Bright Light Therapy for Adolescents With Depression and Eveningness - a Randomized, Placebo-controlled, Assessor-blinded Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 15, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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