Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04944758
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2021-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility of Adherence to Light Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r.lam@ubc.ca', 'phone': '6048227325', 'title': 'Dr. Raymond Lam', 'organization': 'University of British Columbia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Rate of adherence (\\>75% of total daily sessions) to light therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Relapse as defined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a defined event, "relapse", which is based on several criteria, only one of which is the MADRS scale; however this scale does NOT represent part of the outcome and so is not reported here..'}, {'type': 'SECONDARY', 'title': 'Change in Clinician-rated Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Changes in MADRS scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Montgomery-Asberg Depression Rating Scale. MADRS scores range from 0 to 60, with higher scores indicating greater severity of depression (worse outcome).', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient-rated Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Changes in scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Quick Inventory of Depressive Symptomatology, Self-Rated scale (QIDS-SR). The QIDS-SR scores range from 0 to 27, with higher scores indicating greater severity of depression (worse outcome).', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Discontinuation Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Scores on a discontinuation effects scale developed for this study, Antidepressant Discontinuation Symptoms Scale (ADSS). Scores range from 0 to 117, with higher scores indicating more severe discontinuation symptoms (worse outcome).', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Light Therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.\n\nLight therapy: Light therapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-14', 'size': 269564, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-23T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'We received a grant for an expanded feasibility trial that superseded this one.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2021-06-14', 'resultsFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-06', 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence Rate', 'timeFrame': '6 weeks', 'description': 'Rate of adherence (\\>75% of total daily sessions) to light therapy'}], 'secondaryOutcomes': [{'measure': 'Relapse Rate', 'timeFrame': '6 weeks', 'description': 'Relapse as defined.'}, {'measure': 'Change in Clinician-rated Depressive Symptoms', 'timeFrame': '6 weeks', 'description': 'Changes in MADRS scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Montgomery-Asberg Depression Rating Scale. MADRS scores range from 0 to 60, with higher scores indicating greater severity of depression (worse outcome).'}, {'measure': 'Change in Patient-rated Depressive Symptoms', 'timeFrame': '6 weeks', 'description': 'Changes in scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Quick Inventory of Depressive Symptomatology, Self-Rated scale (QIDS-SR). The QIDS-SR scores range from 0 to 27, with higher scores indicating greater severity of depression (worse outcome).'}, {'measure': 'Discontinuation Symptoms', 'timeFrame': '4 weeks', 'description': 'Scores on a discontinuation effects scale developed for this study, Antidepressant Discontinuation Symptoms Scale (ADSS). Scores range from 0 to 117, with higher scores indicating more severe discontinuation symptoms (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major depressive disorder', 'light therapy', 'relapse prevention', 'adherence'], 'conditions': ['Major Depression in Remission']}, 'descriptionModule': {'briefSummary': 'In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of participants meeting eligibility criteria to determine what factors will challenge or enhance adherence to a standard light therapy protocol.', 'detailedDescription': 'Guidelines recommend at least 6-9 months of maintenance treatment to prevent relapse once patients with major depressive disorder (MDD) are in symptom remission with antidepressant treatment. However, many patients decide to discontinue antidepressants because of side effects or personal preference for a non-pharmacological treatment. Hence, a priority question for patients is whether non-pharmacological treatments can be substituted for antidepressants for maintenance treatment.\n\nLight therapy is a safe, evidence-based, non-pharmacological treatment for MDD and seasonal affective disorder (SAD) with fewer side effects than antidepressants. The safety and efficacy of light therapy suggest that it would also be effective for maintenance treatment and relapse prevention, but there are no studies addressing this question.\n\nBefore conducting a randomized controlled trial, we want to determine whether light therapy is feasible for patients in remission with antidepressants and whether patients will adhere to standard light therapy protocols. In this feasibility study, we will enroll patients with MDD in remission who wish to discontinue their antidepressant and substitute open-label light therapy to examine adherence outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\[1\\] Outpatients 19 to 65 years of age;\n* \\[2\\] Diagnostic and Statistical Manual (DSM)-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;\n* \\[3\\] taking an antidepressant for no more than six months;\n* \\[4\\] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;\n* \\[5\\] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale \\[MADRS\\];\n* \\[6\\] Willing and able to complete self-report and online assessments including sufficient fluency in English.\n\nExclusion Criteria:\n\n* \\[1\\] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);\n* \\[2\\] MDD with psychotic features (lifetime);\n* \\[3\\] significant personality disorder diagnosis \\[e.g., borderline, antisocial\\];\n* \\[4\\] High suicidal risk, defined by clinician judgment;\n* \\[5\\] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening;\n* \\[6\\] Significant neurological disorders, head trauma, or other unstable medical conditions;\n* \\[7\\] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers);\n* \\[8\\] history of severe withdrawal effects with antidepressant discontinuation;\n* \\[9\\] retinal disease or other eye condition preventing use of bright light therapy;\n* \\[10\\] use of photosensitizing medication within 1 week of baseline visit.'}, 'identificationModule': {'nctId': 'NCT04944758', 'briefTitle': 'Feasibility of Adherence to Light Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'V2.0_May-17-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Light therapy', 'description': 'Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.', 'interventionNames': ['Device: Light therapy']}], 'interventions': [{'name': 'Light therapy', 'type': 'DEVICE', 'description': 'Light therapy', 'armGroupLabels': ['Light therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'UBC Mood Disorders Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Raymond W Lam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Michael Smith Foundation for Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Raymond Lam', 'investigatorAffiliation': 'University of British Columbia'}}}}