Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-01 @ 2:15 PM
Study NCT ID:
NCT06973759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014467', 'term': 'Ultraviolet Therapy'}], 'ancestors': [{'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of depressive symptoms', 'timeFrame': 'Soon after the intervention', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change of other clinical symptoms', 'timeFrame': 'Soon after the intervention', 'description': 'Change in Beck Depression Inventory (BDI) score, which ranges from 0-63, higher score indicates greater depression severity.'}, {'measure': 'Change of other clinical symptoms', 'timeFrame': 'Soon after the intervention', 'description': 'Change in Pittsburgh Sleep Quality Index (PSQI) score, which ranges from 0-21, higher score indicates poorer sleep quality.'}, {'measure': 'Change of other clinical symptoms', 'timeFrame': 'Soon after the intervention', 'description': '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.'}, {'measure': 'Change of other clinical symptoms', 'timeFrame': 'Soon after the intervention', 'description': 'Change in KIDCSREEN-27 score, which ranges from 30-135, higher score indicates better life quality and social support.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Eveningness', 'Bright light therapy', 'Adolescents'], 'conditions': ['Depression, Unipolar']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Chinese, aged 12-19 years old;\n2. 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;\n3. 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;\n4. Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. \\<12.\n\nExclusion Criteria:\n\n1. 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;\n2. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;\n3. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;\n4. Initiation of or change in antidepressant medication within past 4 weeks;\n5. Having been or is currently receiving any structured psychotherapy;\n6. With hearing or speech deficit;\n7. Night shift worker;\n8. Trans-meridian flight across at least two time zones in the past 3 months and during the study;\n9. Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma."}, 'identificationModule': {'nctId': 'NCT06973759', 'briefTitle': 'Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Bright Light Therapy for Adolescents With Depression and Eveningness - a Randomized, Placebo-controlled, Assessor-blinded Study', 'orgStudyIdInfo': {'id': '2024.494-T'}, 'secondaryIdInfos': [{'id': '12230316', 'type': 'OTHER_GRANT', 'domain': 'Health and Medical Research Fund (HMRF), Food and Health Bureau, Hong Kong'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright light therapy group', 'description': 'Blue-enriched white light', 'interventionNames': ['Device: Bright light therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dim red light group', 'description': 'Dim red light', 'interventionNames': ['Device: Dim red light']}], 'interventions': [{'name': 'Bright light therapy', 'type': 'DEVICE', 'description': 'Exposure to blue-enriched white light for 15-30 minutes a day for 8 weeks', 'armGroupLabels': ['Bright light therapy group']}, {'name': 'Dim red light', 'type': 'DEVICE', 'description': 'Exposure to dim red light for 15-30 minutes a day for 8 weeks.', 'armGroupLabels': ['Dim red light group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '999077', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Joey WY Chan, FHKAM(Psych)', 'role': 'CONTACT', 'email': 'joeywychan@cuhk.edu.hk', 'phone': '+862 39197647'}, {'name': 'Xingle Gao', 'role': 'CONTACT', 'email': 'xinglegao@link.cuhk.edu.hk', 'phone': '+852 92916602'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Joey WY Chan', 'role': 'CONTACT', 'email': 'joeywychan@cuhk.edu.hk', 'phone': '+852 39197647'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Joey WY Chan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}