Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT00752960
Status:
UNKNOWN
Last Update Posted:
2008-09-16
First Post:
2008-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA extracted from whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-12', 'studyFirstSubmitDate': '2008-09-12', 'studyFirstSubmitQcDate': '2008-09-12', 'lastUpdatePostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diabetic metabolic symptoms (DiMS): body weight, body mass index, waist circumference, blood pressure, triglycerides, total, LDL, and HDL cholesterol, blood glucose', 'timeFrame': 'after treatment with antipsychotic medication(s) for => 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['single nucleotide polymorphism, SNP, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome'], 'conditions': ['Psychoses']}, 'referencesModule': {'references': [{'pmid': '17487003', 'type': 'BACKGROUND', 'citation': 'Ruano G, Blair CL, Bower B, Windemuth A, Kocherla M, Aleman Y, Pearlson G, Goethe JW, Schwartz HI. Somatic complications of psychotropic medications in a patient with multiple CYP2 drug metabolism deficiencies. Conn Med. 2007 Apr;71(4):197-200.'}, {'pmid': '17346932', 'type': 'BACKGROUND', 'citation': 'de Leon J, Susce MT, Johnson M, Hardin M, Pointer L, Ruano G, Windemuth A, Diaz FJ. A clinical study of the association of antipsychotics with hyperlipidemia. Schizophr Res. 2007 May;92(1-3):95-102. doi: 10.1016/j.schres.2007.01.015. Epub 2007 Mar 8.'}, {'pmid': '17199131', 'type': 'BACKGROUND', 'citation': 'Ruano G, Goethe JW, Caley C, Woolley S, Holford TR, Kocherla M, Windemuth A, de Leon J. Physiogenomic comparison of weight profiles of olanzapine- and risperidone-treated patients. Mol Psychiatry. 2007 May;12(5):474-82. doi: 10.1038/sj.mp.4001944. Epub 2007 Jan 2.'}, {'pmid': '21851846', 'type': 'DERIVED', 'citation': 'Windemuth A, de Leon J, Goethe JW, Schwartz HI, Woolley S, Susce M, Kocherla M, Bogaard K, Holford TR, Seip RL, Ruano G. Validation of candidate genes associated with cardiovascular risk factors in psychiatric patients. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Mar 30;36(2):213-9. doi: 10.1016/j.pnpbp.2011.08.001. Epub 2011 Aug 6.'}], 'seeAlsoLinks': [{'url': 'http://www.instituteofliving.org/', 'label': 'Institute of Living, Hartford Hospital, Hartford, CT'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess patients treated with the antipsychotics aripiprazole (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), or ziprasidone (Geodon®) and to identify genetic variations more commonly found in individuals who develop diabetic metabolic signs and symptoms, which include changes in blood lipids, blood glucose, blood pressure, and body weight.', 'detailedDescription': 'As many as 30% of psychiatric patients experience weight gain, central deposition of fat, dyslipidemia, increased blood glucose and hypertension--diabetic metabolic symptoms--upon treatment with atypical antipsychotic medication. As a result, cardiovascular disease risk is significantly increased.\n\nThe long-term goal of this collaborative study is to identify, for each individual atypical antipsychotic (AAP) medication, the gene variations associated with elevated risk of diabetic metabolic symptoms (DiMS). If such genes are identified, in the future genetic testing may help mental health care professionals choose treatment while minimizing the risk of undesirable side effects of antipsychotics. We propose to develop a novel product termed "Physiotype" to deliver personalized information for each patient on the drug specific risks among aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. The Physiotype consists of a multi-gene ensemble of single nucleotide polymorphisms (SNPs) that, interpreted with a biomathematical algorithm, may explain most of the inter-individual differences in DiMS among the 5 AAPs. If this study does identify related genes, genetic tests will be developed to provide patients and health care professionals with tools to identify those patients who are at risk of developing adverse metabolic side effects to antipsychotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for psychoses', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receiving atypical antipsychotic therapy (olanzapine, aripiprazole, quetiapine, risperidone, or ziprasidone) for 3 months\n* who have taken \\>50% of the prescribed dose for the last month.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00752960', 'acronym': 'DIMS', 'briefTitle': 'DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genomas, Inc'}, 'officialTitle': 'DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics', 'orgStudyIdInfo': {'id': 'R44MH073291', 'link': 'https://reporter.nih.gov/quickSearch/R44MH073291', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '50R44 MH073291-03'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Patients receiving olanzapine'}, {'label': 'B', 'description': 'patients receiving risperidone'}, {'label': 'C', 'description': 'Patients receiving quetiapine'}, {'label': 'D', 'description': 'Patients receiving aripiprazole'}, {'label': 'E', 'description': 'patients receiving ziprasidone'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Woolley, PhD', 'role': 'CONTACT', 'email': 'Swoolle@harthosp.org', 'phone': '860-545-7329'}, {'name': 'John D. Goethe, MD', 'role': 'CONTACT', 'email': 'jgoethe@harthosp.org', 'phone': '860-545-7118'}, {'name': 'John W Goethe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Hospital Institute of Living', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose de Leon, MD', 'role': 'CONTACT', 'email': 'jdeleon@uky.edu', 'phone': '859-246-7563'}, {'name': 'Jose de Leon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Steven Woolley, PhD', 'role': 'CONTACT', 'email': 'swoolle@harthosp.org', 'phone': '860-545-7329'}], 'overallOfficials': [{'name': 'Gualberto Ruano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genomas, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genomas, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hartford Hospital', 'class': 'OTHER'}, {'name': 'University of Kentucky', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gualberto Rauno, MD, PhD/President', 'oldOrganization': 'Genomas, Inc.'}}}}