Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-31 @ 4:17 PM
Study NCT ID:
NCT04761861
Status:
WITHDRAWN
Last Update Posted:
2025-07-14
First Post:
2021-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Institutional and funding constrains', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'body mass index', 'timeFrame': '12 weeks', 'description': 'body mass index'}], 'primaryOutcomes': [{'measure': 'low-density lipoprotein cholesterol', 'timeFrame': 'week 12', 'description': 'low-density lipoprotein cholesterol'}], 'secondaryOutcomes': [{'measure': 'high-density lipoprotein cholesterol', 'timeFrame': 'week 12', 'description': 'high-density lipoprotein cholesterol'}, {'measure': 'Serum stem cell growth factor beta', 'timeFrame': 'week 12', 'description': 'Serum stem cell growth factor beta'}, {'measure': 'FAM19A5 serum level', 'timeFrame': '12 weeks', 'description': 'FAM19A5 serum level'}, {'measure': 'TNF-alpha serum level', 'timeFrame': '12 weeks', 'description': 'TNF-alpha serum level'}, {'measure': 'Adverse drug reactions', 'timeFrame': '12 weeks', 'description': 'Adverse drug reactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.\n\nExclusion Criteria:\n\n* liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT04761861', 'briefTitle': 'Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia', 'organization': {'class': 'OTHER', 'fullName': 'Sadat City University'}, 'officialTitle': 'Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': '10/2021NEUR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'description': 'Vildagliptin 50 mg tablet daily', 'interventionNames': ['Drug: Vildagliptin 50 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vildagliptin 50 MG', 'type': 'DRUG', 'description': 'Vildagliptin 50 MG tablet once daily', 'armGroupLabels': ['Vildagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo one tablet daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13829', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'country': 'Egypt', 'facility': 'Faculty of Pharmacy', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sadat City University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Mahmoud Samy Abdallah', 'investigatorAffiliation': 'Sadat City University'}}}}