Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 12:11 PM
Study NCT ID:
NCT01811160
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2013-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, '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'}]}}, '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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-12', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight change', 'timeFrame': 'Mean change from baseline weight at 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean change in systolic blood pressure', 'timeFrame': 'Mean change from baseline systolic blood pressure at 8 weeks'}, {'measure': 'Mean change diastolic blood pressure', 'timeFrame': 'Mean change from baseline diastolic blood pressure at 8 weeks'}, {'measure': 'Mean change waist circumference', 'timeFrame': 'Mean change from baseline waist circumference at 8 weeks'}, {'measure': 'Mean change hip circumference', 'timeFrame': 'Mean change from baseline hip circumference at 8 weeks'}, {'measure': 'Mean change fat mass', 'timeFrame': 'Mean change from baseline fat mass at 8 weeks'}, {'measure': 'Mean change lean mass', 'timeFrame': 'Mean change from baseline lean mass at 8 weeks'}, {'measure': 'Mean change total body water', 'timeFrame': 'Mean change from baseline total body water at 8 weeks'}, {'measure': 'Mean change glucose', 'timeFrame': 'Mean change from baseline glucose at 8 weeks'}, {'measure': 'Mean change low density lipoprotein', 'timeFrame': 'Mean change from baseline low density lipoprotein at 8 weeks'}, {'measure': 'Mean change high density lipoprotein', 'timeFrame': 'Mean change from baseline high density lipoprotein at 8 weeks'}, {'measure': 'Mean change triglycerides', 'timeFrame': 'Mean change from baseline triglycerides at 8 weeks'}, {'measure': 'Mean change cholesterol', 'timeFrame': 'Mean change from baseline cholesterol at 8 weeks'}, {'measure': 'Mean change Hamilton D scores', 'timeFrame': 'Mean change from baseline Hamilton D score at 8 weeks'}, {'measure': 'Mean change Young Mania rating scale', 'timeFrame': 'Mean change from baseline Young Mania rating scale at 8 weeks'}, {'measure': 'Mean change Positive and Negative Symptoms scale', 'timeFrame': 'Mean change from baseline Positive and Negative Symptoms scale at 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melatonin', 'Second generation antipsychotic', 'bipolar disorder', 'schizophrenia', 'Metabolic'], 'conditions': ['Second Generation Antipsychotic Induced Metabolic Adverse Effects']}, 'descriptionModule': {'briefSummary': 'Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute and long term treatment of these disorders and are considered a first option on most treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain, disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality as well as non- adherence to treatment. There are several hypotheses attempting to explain the complex pathways that lead to antipsychotic therapeutic effects and their accompanying adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent the body weight increase, which indicates a possible role for biological rhythms in SGA induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that follows a circadian rhythm with an increased secretion in the middle of the night. This hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and periphery. Thus melatonin is involved in a series of biological functions such as sleep regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more recently in the regulation of metabolic processes including insulin, leptin, and lipid regulation.\n\nGiven previous results in experimental animals, the purpose of the present study is to test the potential effect of melatonin in reducing or preventing some of the metabolic disturbances associated with SGA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and non-pregnant, non-lactating women aged between 18 and 45 years;\n2. DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;\n3. free of concomitant medical or neurological illness (as per review of systems and general physical examination);\n4. free of DSM-IV current substance abuse or a history of substance dependence in the last six months;\n5. who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.\n\nExclusion Criteria:\n\n1. were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;\n2. had a history of hypersensitivity to melatonin;\n3. exhibited high risk for suicide or high risk for aggressiveness;\n4. women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.'}, 'identificationModule': {'nctId': 'NCT01811160', 'briefTitle': 'Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente'}, 'officialTitle': 'Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics', 'orgStudyIdInfo': {'id': 'INPRF_144'}, 'secondaryIdInfos': [{'id': 'INPRF_144', 'type': 'OTHER_GRANT', 'domain': 'Instituto Nacional de Psiquiatría No. 144'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin 5mg (extended release capsules)', 'description': 'Subjects received melatonin (extended release) 5mg nightly during the follow up period', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received a placebo capsule nightly during the eight week follow up period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'otherNames': ['Melatonin 5mg capsules were administered at 20:00hrs during the follow up period.'], 'description': 'A capsule of melatonin was administered nightly (20:00hrs).', 'armGroupLabels': ['Melatonin 5mg (extended release capsules)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules were administered at 20:00hrs for eight weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14370', 'city': 'Mexico City', 'state': 'México City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Psiquiatría "Dr. Ramón de la Fuente"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Francisco Romo-Nava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Psiquiatría / UNAM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Francisco Romo Nava', 'investigatorAffiliation': 'Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente'}}}}