Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT02448433
Status:
UNKNOWN
Last Update Posted:
2015-05-19
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phototherapy in Young People With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2015-05-14', 'studyFirstSubmitQcDate': '2015-05-14', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Depression', 'timeFrame': 'Between baseline and post (4 weeks) intervention', 'description': 'Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)'}], 'secondaryOutcomes': [{'measure': 'Severity of Depression', 'timeFrame': 'Score between baseline and follow up (8 weeks)', 'description': 'Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)'}, {'measure': 'Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression', 'timeFrame': 'Between baseline and post (4 weeks) intervention', 'description': 'Associations between changes in sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)'}, {'measure': 'Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression', 'timeFrame': 'Baseline and post (4 weeks) intervention', 'description': 'Associations between the initial sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)'}, {'measure': 'Subjective Sleep Quality', 'timeFrame': 'Between baseline and post (4 weeks) intervention', 'description': 'Change in Leeds Sleep Evaluation Questionnaire score'}, {'measure': 'Fatigue Severity', 'timeFrame': 'Between baseline and post (4 weeks) intervention', 'description': 'Change in Fatigue Severity Scale score'}]}, 'conditionsModule': {'keywords': ['Phototherapy', 'Light', 'Depression', 'Sleep and circadian disturbances', 'Youth'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered.\n\nThe main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Quick Inventory of Depressive Symptomatology score \\> 6;\n2. First episode of depression before age 25;\n3. Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.\n\nExclusion Criteria:\n\n1. Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;\n2. Other primary psychiatric disorders aside from anxiety disorders;\n3. Significant alcohol or other substance dependence;\n4. Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study);\n5. Use of medications that may interact with light to produce a photoallergic reaction;\n6. Eye or skin condition which may interact with bright light exposure;\n7. Regular shift-work within 60-days prior to entry into the study;\n8. Recent transmeridian travel.'}, 'identificationModule': {'nctId': 'NCT02448433', 'briefTitle': 'Phototherapy in Young People With Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Ottawa'}, 'officialTitle': 'Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms', 'orgStudyIdInfo': {'id': '2015007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Phototherapy', 'interventionNames': ['Device: Phototherapy light-emitting glasses']}], 'interventions': [{'name': 'Phototherapy light-emitting glasses', 'type': 'DEVICE', 'otherNames': ['Re-timer'], 'description': 'The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m\\^2) upon awakening and progressive shift to earlier wake-up times.\n\nParticipants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention.\n\nDuring the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.', 'armGroupLabels': ['Phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'SUSPENDED', 'country': 'Australia', 'facility': 'Brain and Mind Research Insitute, The University of Sydney', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': 'K1Z 7K4', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rébecca Robillard, PhD', 'role': 'CONTACT', 'email': 'reb.robillard@gmail.com', 'phone': '+1 613 722 6521', 'phoneExt': '6279'}], 'facility': 'Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Rébecca Robillard, PhD', 'role': 'CONTACT', 'email': 'reb.robillard@gmail.com', 'phone': '+1 613 722 6521', 'phoneExt': '6279'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ottawa', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Rébecca Robillard', 'investigatorAffiliation': 'University of Ottawa'}}}}