NCT06973759

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Nov 2025Jun 2028

First Submitted

Initial submission to the registry

April 23, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

April 23, 2025

Last Update Submit

March 18, 2026

Conditions

Depression, Unipolar

Keywords

DepressionEveningnessBright light therapyAdolescents

Outcome Measures

Primary Outcomes (1)

  • Change of depressive symptoms

    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.

    Soon after the intervention

Secondary Outcomes (4)

  • Change of other clinical symptoms

    Soon after the intervention

  • Change of other clinical symptoms

    Soon after the intervention

  • Change of other clinical symptoms

    Soon after the intervention

  • Change of other clinical symptoms

    Soon after the intervention

Study Arms (2)

Bright light therapy group

EXPERIMENTAL

Blue-enriched white light

Device: Bright light therapy

Dim red light group

PLACEBO COMPARATOR

Dim red light

Device: Dim red light

Interventions

Dim red lightDEVICE

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

Dim red light group
Bright light therapyDEVICE

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

Bright light therapy group

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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-Ă–stberg Morning-Eveningness Questionnaire (rMEQ), i.e. \<12.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Central Study Contacts

Joey WY Chan

CONTACT

+852 39197647joeywychan@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The subjects will be explained that the study aims to test the efficacy of the different modalities of non-pharmacological treatments for depression including bright light therapy and dim red light, without mentioning which one is the placebo. An independent outcome assessor will be blinded to the treatment allocation throughout the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 15, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)