Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 7:15 AM
Study NCT ID:
NCT00852592
Status:
COMPLETED
Last Update Posted:
2016-11-07
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
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Scores range from 0-100 with higher values representing higher functioning and better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Light Unit', 'description': 'active light therapy unit: dosage - 15-60minutes NOON-2PM daily'}, {'id': 'FG001', 'title': 'Inactive Light Unit', 'description': 'Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Comparator', 'description': 'active light unit\n\nactive light therapy unit: dosage - 15-60minutes NOON-2PM daily'}, {'id': 'BG001', 'title': 'Inactive Comparator', 'description': 'inactive light unit\n\nInactive light therapy unit: dosage: 15-60minutes NOON-2PM daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '12', 'groupId': 'BG000'}, {'value': '45', 'spread': '15', 'groupId': 'BG001'}, {'value': '44', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'SIGH-ADS depression score', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '30.1', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global Assessment of Functioning (GAF)', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '5.61', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '5.32', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '5.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Global Assessment of Function (GAF) was used to assess psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2009-02-25', 'resultsFirstSubmitDate': '2016-02-19', 'studyFirstSubmitQcDate': '2009-02-26', 'lastUpdatePostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-20', 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SIGH-ADS Depression Score', 'timeFrame': '6 weeks', 'description': 'The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Global Assessment of Functioning (GAF)', 'timeFrame': '6-weeks', 'description': 'The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bipolar Disorder Depression Midday Light Therapy', 'Bipolar Disorder Type I or II'], 'conditions': ['Bipolar Disorder', 'Major Depressive Episode']}, 'referencesModule': {'references': [{'pmid': '28969438', 'type': 'DERIVED', 'citation': 'Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the efficacy of light therapy for bipolar depression.', 'detailedDescription': 'Bipolar Disorders (BD) are associated with chronic depression, disability, and increased suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind, placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-65 years\n* DSM-IV Criteria BD I or II depressive episode,\n* SIGH-ADS \\>20; duration \\>2 weeks.\n* Stable dose antidepressant drug \\>8 weeks with concurrent antimanic drug\n* Controlled thyroid disease\n* Subjects with preexisting eye diseases will be included.\n* Able to provide informed consent\n* Stable minimum dose antimanic drug \\>4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.\n* Stable unchanged psychotherapy for \\>16weeks\n\nExclusion Criteria:\n\n* The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,\n* Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.\n* Acute psychosis (DSM-IV Criteria)\n* Rapid cycling in the past 1 year\n* Obsessive compulsive disorder\n* Alcohol or substance abuse or dependence in the past 6 months.\n* MRS\\>5\n* Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 \\>2)\n* Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS'}, 'identificationModule': {'nctId': 'NCT00852592', 'briefTitle': 'Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PRO09020546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': '7000lux broad-spectrum light', 'interventionNames': ['Device: 7000lux broad-spectrum light']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inactive Comparator', 'description': '50lux dim red light', 'interventionNames': ['Device: 50lux dim red light']}], 'interventions': [{'name': '7000lux broad-spectrum light', 'type': 'DEVICE', 'description': 'dosage - 15-60minutes NOON-2PM daily', 'armGroupLabels': ['Active Comparator']}, {'name': '50lux dim red light', 'type': 'DEVICE', 'description': 'dosage: 15-60minutes NOON-2PM daily', 'armGroupLabels': ['Inactive Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, Western Psychiatric Institute and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Dorothy K Sit, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We can share data if approached by other investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Dorothy Sit', 'investigatorAffiliation': 'Northwestern University'}}}}