Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness

Not Applicable

Not yet recruiting

• Conditions: Depression, Unipolar

• Registration Number: NCT06973759
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-07-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Chinese, aged 12-19 years old;
2. 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;
3. 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;
4. Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. <12.

Exclusion Criteria

1. 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;
2. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;
3. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
4. Initiation of or change in antidepressant medication within past 4 weeks;
5. Having been or is currently receiving any structured psychotherapy;
6. With hearing or speech deficit;
7. Night shift worker;
8. Trans-meridian flight across at least two time zones in the past 3 months and during the study;
9. Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of depressive symptoms	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 Outcome Measures

Name	Time	Method
Change of other clinical symptoms	Soon after the intervention	Change in KIDCSREEN-27 score, which ranges from 30-135, higher score indicates better life quality and social support.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong