Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT01048294
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2010-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016574', 'term': 'Seasonal Affective Disorder'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-10', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2010-01-12', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SIGH SAD depression observer rating', 'timeFrame': 'days 1, 8, 15, 22'}], 'secondaryOutcomes': [{'measure': 'selfrating of depressive mood', 'timeFrame': 'once daily during 22 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Seasonal affective disorder', 'phototherapy', 'circadian rhythms', 'blue enriched light', 'melanopsin', 'Primary disease: Seasonal Affective Disorder, winter type'], 'conditions': ['Seasonal Affective Disorder']}, 'referencesModule': {'references': [{'pmid': '21911257', 'type': 'DERIVED', 'citation': "Gordijn MCM, 't Mannetje D, Meesters Y. The effects of blue-enriched light treatment compared to standard light treatment in Seasonal Affective Disorder. J Affect Disord. 2012 Jan;136(1-2):72-80. doi: 10.1016/j.jad.2011.08.016. Epub 2011 Sep 10."}]}, 'descriptionModule': {'briefSummary': 'One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms. Since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat SAD. In chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. In the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients., The investigators hypothesise that blue- enriched light improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65;\n* diagnosis of Seasonal affective Disorder, winter type according to DSM-IV;\n* SIGH SAD rating higher then or equal to 18 on day 1;\n* no other treatments for mood disorder during the study\n* stay in the Netherlands during the study\n\nExclusion Criteria:\n\n* other Axis 1 disorder according to DSM-IV\n* acute suicide risk\n* use of psychotropic drugs or photosensitizing drugs\n* eye diseases other then usual effect of aging\n* diabetes or epilepsy\n* regular shift work'}, 'identificationModule': {'nctId': 'NCT01048294', 'briefTitle': 'Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Gerandomiseerde en Gecontroleerde Studie Naar de Effecten Van Lichttoediening Met Een Hogere Kleurtemperatuur in Vergelijking Met de Standaard Lichttherapie in de Behandeling Van Winterdepressie', 'orgStudyIdInfo': {'id': 'METc2005/160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Light Treatment', 'description': '30 min of Standard bright light treatment (color 5000K)', 'interventionNames': ['Device: Original Energy Light,']}, {'type': 'EXPERIMENTAL', 'label': 'Blue enriched Light treatment 20 min', 'description': '20 minutes of Blue enriched light treatment (color 17000K)', 'interventionNames': ['Device: Original Energy Light prototype']}, {'type': 'EXPERIMENTAL', 'label': 'Blue enriched light treatment 30 min', 'description': '30 minutes of Blue enriched light treatment (color 17000K)', 'interventionNames': ['Device: Original Energy Light prototype']}], 'interventions': [{'name': 'Original Energy Light,', 'type': 'DEVICE', 'otherNames': ['Philips energy light HF 3308; 2 lamps PLL36W color 5000K'], 'description': '9000 lux, 30 minutes in the morning', 'armGroupLabels': ['Standard Light Treatment']}, {'name': 'Original Energy Light prototype', 'type': 'DEVICE', 'otherNames': ['Philips energy light HF 3308; 2 lamps PLL36W color 17000K'], 'description': '9000 lux 20 minutes in the morning', 'armGroupLabels': ['Blue enriched Light treatment 20 min']}, {'name': 'Original Energy Light prototype', 'type': 'DEVICE', 'otherNames': ['Philips energy light HF 3308; 2 lamps PLL36W color 17000K'], 'description': '9000 lux 30 minutes in the morning', 'armGroupLabels': ['Blue enriched light treatment 30 min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Department of Psychiatry, University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Y. Meesters, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Psychiatry, University Medical Center Groningen, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ybe Meesters, PhD', 'oldOrganization': 'University Medical Center Groningen'}}}}