Adjunctive Bright Light Therapy in Adolescents With Depre... | NCT06973759

Studies
Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness

NCT06973759

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Depression, Unipolar

Interventions

Bright light therapy
Dim red light

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12230316	Other Grant/Funding Number	Health and Medical Research Fund (HMRF), Food and Health Bureau, Hong Kong

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Actual

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Apr 23, 2025

First Submission Date that Met QC Criteria

May 7, 2025

First Posted Date

May 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bright light therapy	Device	Exposure to blue-enriched white light for 15-30 minutes a day for 8 weeks	Bright light therapy group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change of other clinical symptoms	Change in Beck Depression Inventory (BDI) score, which ranges from 0-63, higher score indicates greater depression severity.	Soon after the intervention
Change of other clinical symptoms

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Joey WY Chan	Contact	+852 39197647		joeywychan@cuhk.edu.hk

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong	Recruiting	Hong Kong	Hong Kong	999077	Hong Kong

ID	Term
D003866	Depressive Disorder
D003863	Depression

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D014467	Ultraviolet Therapy

ID	Term
D010789	Phototherapy
D013812	Therapeutics

Masking Info

Masking

Double

Masking Description

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.

Who Masked

ParticipantOutcomes Assessor