Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-30 @ 7:42 PM
Study NCT ID:
NCT00595504
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
2008-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
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Henderson, M.D.', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The limitations of this study include the relatively small sample size and short intervention period (8 weeks).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ramelteon', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'sugar pill', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'A double-blind, placebo-controlled, 8-week pilot trial was 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'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis (intent to treat) were those that completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ramelteon'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'sugar pill'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the Freedom Trial Clinic at the Erich Lindemann Mental Health Center and were studied at the Mallinckrodt General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston', 'preAssignmentDetails': 'After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ramelteon'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'sugar pill'}, {'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': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', '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': '49', 'spread': '7', 'groupId': 'BG000'}, {'value': '56', 'spread': '9', 'groupId': 'BG001'}, {'value': '53', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2008-01-07', 'resultsFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-14', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline and Week 8', 'description': 'A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.'}, {'measure': 'Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).', 'timeFrame': 'Baseline and Week 8', 'description': 'A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.'}, {'measure': 'Change in Abdominal Fat (DEXA).', 'timeFrame': 'Baseline and Week 8', 'description': 'A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'metabolism', 'antipsychotics', 'diabetes', 'rozerem'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorders']}, 'referencesModule': {'references': [{'pmid': '15328901', 'type': 'BACKGROUND', 'citation': 'Ananth J, Venkatesh R, Burgoyne K, Gadasalli R, Binford R, Gunatilake S. 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Acta Psychiatr Belg. 1986 Mar-Apr;86(2):141-51.'}]}, 'descriptionModule': {'briefSummary': 'This study involves people who have schizophrenia or schizoaffective disorder who are currently taking antipsychotic medications. Some antipsychotic medications may cause weight gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this study is to find out what happens if another medication (ramelteon) is used along with your antipsychotic medication. We want to find out whether doing this will:\n\n* Change the way your body breaks down fat and sugar.\n* Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).\n* Improve how your body responds to insulin.\n* Affect your quality of sleep.\n* Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug Administration (FDA) to treat people that have difficulty falling asleep. It is not approved for such things as affecting waist size or improving how the body breaks down fat and sugar. Its use in this study is investigational.', 'detailedDescription': 'This is an 8-week randomized, double blind, placebo-controlled pilot study with 4- week follow up assessment, of ramelteon 8 mg/day, administered to subjects for 8 consecutive weeks as an adjunctive therapy in 40 non-diabetic schizophrenia subjects to examine ramelteon effects on body composition, glucose and lipid metabolism, sleep quality and symptoms of tardive dyskinesia using the Massachusetts General Hospital General Clinical Research Center. As far as we know, no previous study has been done to explore the potential role of ramelteon in improving metabolic, sleep, and movement disturbances in schizophrenia subjects. The novel approach of adjunctive ramelteon treatment in the schizophrenia population is promising.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder\n* male or female, age 18-65 years\n* treatment with clozapine, olanzapine, quetiapine or risperidone\n* well established compliance with medications\n* Body Mass Index (BMI) of \\> 27 Kg/m² with any component of metabolic syndrome or insulin resistance or a BMI of \\> 30 Kg/m²:\n\nExclusion Criteria:\n\n* inability to provide informed consent\n* substance and alcohol abuse\n* significant medical illness, including congestive heart failure, severe hepatic impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea, severe cardiovascular disease or renal disease\n* current history of diabetes mellitus or thyroid disease\n* women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study\n* psychiatrically unstable, patients with major depression\n* patients treated with medications known to affect glucose tolerance such as birth control pills containing norgestrel, steroids, beta blockers, anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; and agents that induce weight loss will be excluded from the study\n* treatment with fluvoxamine in the or ketoconazole past two weeks\n* treatment with fluconazole (a strong CYP2C9 inhibitor).\n* subjects treated with ziprasidone and aripiprazole conventional agents\n* treatment with sedative-hypnotics such as barbiturates, zolpidem, eszopiclone, zaleplon. The use of stable daily doses of benzodiazepines is allowed.\n* known hypersensitivity to ramelteon or any of its components'}, 'identificationModule': {'nctId': 'NCT00595504', 'briefTitle': 'Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '2007P-001929'}, 'secondaryIdInfos': [{'id': 'FWA00003136'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Ramelteon 8mg/day', 'interventionNames': ['Drug: Ramelteon']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'sugar pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ramelteon', 'type': 'DRUG', 'otherNames': ['Rozerem'], 'description': 'Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Freedom Trail Clinic', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David C. Henderson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'David C. Henderson', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}