Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00692094
Status:
TERMINATED
Last Update Posted:
2019-11-27
First Post:
2008-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blind Elderly Melatonin Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001766', 'term': 'Blindness'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irb@ohsu.edu', 'phone': '1-877-733-8313', 'title': 'OHSU Integrity Department', 'organization': 'Oregon Health and Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Analyses were not completed because, a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.'}}, 'adverseEventsModule': {'description': 'The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.', 'eventGroups': [{'id': 'EG000', 'title': 'Melatonin: 0.025 Mg-0.5 mg (Delay Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Melatonin: 0.025 mg - 0.5 mg (Advance Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Melatonin: 0.025 mg - 10 mg (Advance Timing)', 'description': "Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Melatonin: 0.025 mg - 20 mg (Advance Timing)', 'description': 'Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin: 0.025 Mg-0.5 mg (Delay Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."}, {'id': 'OG001', 'title': 'Melatonin: 0.025 mg - 0.5 mg (Advance Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'OG002', 'title': 'Melatonin: 0.025 mg - 10 mg (Advance Timing)', 'description': "Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'OG003', 'title': 'Melatonin: 0.025 mg - 20 mg (Advance Timing)', 'description': 'Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.'}], 'timeFrame': 'biweekly throughout the entire study', 'reportingStatus': 'POSTED', 'populationDescription': 'The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.'}, {'type': 'SECONDARY', 'title': 'Durability and Toxicity Side Effects Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin: 0.025 Mg-0.5 mg (Delay Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."}, {'id': 'OG001', 'title': 'Melatonin: 0.025 mg - 0.5 mg (Advance Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'OG002', 'title': 'Melatonin: 0.025 mg - 10 mg (Advance Timing)', 'description': "Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'OG003', 'title': 'Melatonin: 0.025 mg - 20 mg (Advance Timing)', 'description': 'Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melatonin: 0.025 Mg-0.5 mg (Delay Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."}, {'id': 'FG001', 'title': 'Melatonin: 0.025 mg - 0.5 mg (Advance Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'FG002', 'title': 'Melatonin: 0.025 mg - 10 mg (Advance Timing)', 'description': "Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'FG003', 'title': 'Melatonin: 0.025 mg - 20 mg (Advance Timing)', 'description': 'Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Melatonin: 0.025 Mg-0.5 mg (Delay Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."}, {'id': 'BG001', 'title': 'Melatonin: 0.025 mg - 0.5 mg (Advance Timing)', 'description': "Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'BG002', 'title': 'Melatonin: 0.025 mg - 10 mg (Advance Timing)', 'description': "Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."}, {'id': 'BG003', 'title': 'Melatonin: 0.025 mg - 20 mg (Advance Timing)', 'description': 'Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.\n\nMelatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Race and Ethnicity Not Collected', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2008-05-30', 'resultsFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-08', 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.', 'timeFrame': 'biweekly throughout the entire study'}], 'secondaryOutcomes': [{'measure': 'Durability and Toxicity Side Effects Questionnaire', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['melatonin', 'circadian rhythms', 'sleep'], 'conditions': ['Blindness']}, 'referencesModule': {'references': [{'pmid': '10810544', 'type': 'BACKGROUND', 'citation': 'Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. doi: 10.1007/0-306-46814-x_51. No abstract available.'}, {'pmid': '11027741', 'type': 'BACKGROUND', 'citation': 'Sack RL, Brandes RW, Kendall AR, Lewy AJ. Entrainment of free-running circadian rhythms by melatonin in blind people. N Engl J Med. 2000 Oct 12;343(15):1070-7. doi: 10.1056/NEJM200010123431503.'}, {'pmid': '11684046', 'type': 'BACKGROUND', 'citation': 'Lewy AJ, Bauer VK, Hasler BP, Kendall AR, Pires ML, Sack RL. Capturing the circadian rhythms of free-running blind people with 0.5 mg melatonin. Brain Res. 2001 Nov 9;918(1-2):96-100. doi: 10.1016/s0006-8993(01)02964-x.'}, {'pmid': '16393710', 'type': 'RESULT', 'citation': 'Lewy AJ, Emens JS, Lefler BJ, Yuhas K, Jackman AR. Melatonin entrains free-running blind people according to a physiological dose-response curve. Chronobiol Int. 2005;22(6):1093-106. doi: 10.1080/07420520500398064.'}]}, 'descriptionModule': {'briefSummary': 'The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.', 'detailedDescription': "The investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 4 treatment plans differ only in the start dose and the time of administration. Successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 55-100 years old\n* Blindness for at least one year, verified by an ophthalmologic exam\n* Ability to comply with the requirements of the experimental protocol\n* No clinically significant abnormalities (other than blindness) on a general physical examination\n* Subjects must be competent to sign informed consent\n\nExclusion Criteria:\n\n* Abnormal heart, liver or kidney function; a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual\n* A diagnosis of obstructive sleep apnea (apnea index \\> 10) or nocturnal myoclonus (\\> 10 associated arousals/hour)\n* External demands that limit the ability to maintain a regular schedule, e.g., night shift work'}, 'identificationModule': {'nctId': 'NCT00692094', 'briefTitle': 'Blind Elderly Melatonin Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Melatonin Entrainment of Elderly Blind Free-runners', 'orgStudyIdInfo': {'id': 'eIRB 0194'}, 'secondaryIdInfos': [{'id': 'R01AG021826', 'link': 'https://reporter.nih.gov/quickSearch/R01AG021826', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': "Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.", 'interventionNames': ['Biological: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': "Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.", 'interventionNames': ['Biological: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': "Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.", 'interventionNames': ['Biological: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.', 'interventionNames': ['Biological: Melatonin']}], 'interventions': [{'name': 'Melatonin', 'type': 'BIOLOGICAL', 'description': '0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.', 'armGroupLabels': ['1']}, {'name': 'Melatonin', 'type': 'BIOLOGICAL', 'description': '0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.', 'armGroupLabels': ['2']}, {'name': 'Melatonin', 'type': 'BIOLOGICAL', 'description': '0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.', 'armGroupLabels': ['3']}, {'name': 'Melatonin', 'type': 'BIOLOGICAL', 'description': '0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Sleep and Mood Disorders Lab, Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Alfred J Lewy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}