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Recruiting NCT06973759

Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness

No phase Interventional Depression, Unipolar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bright light therapy, Dim red light.
Who it may be relevant to
Registry conditions: Depression, Unipolar. Basic parameters: 12 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device Bright light therapy
    Exposure to blue-enriched white light for 15-30 minutes a day for 8 weeks
  • Device Dim red light
    Exposure to dim red light for 15-30 minutes a day for 8 weeks.

Primary outcome measures

  • Change of depressive symptoms [Time frame: Soon after the intervention]
Secondary outcome measures (4)
  • Change of other clinical symptoms [Time frame: Soon after the intervention]
  • Change of other clinical symptoms [Time frame: Soon after the intervention]
  • Change of other clinical symptoms [Time frame: Soon after the intervention]
  • Change of other clinical symptoms [Time frame: Soon after the intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06973759 · 2024.494-T · 12230316

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗