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Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness

ConditionDepression, Unipolar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Bright light therapy groupExperimental treatment 1 intervention
Group B: Dim red light groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Soon after the intervention

Secondary outcomes

1

Change of other clinical symptoms

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

Time frame
Soon after the intervention
2

Change of other clinical symptoms

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

Time frame
Soon after the intervention
3

Change of other clinical symptoms

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.

Time frame
Soon after the intervention
4

Change of other clinical symptoms

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

Time frame
Soon after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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