Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT04127058
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2019-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081732', 'term': 'iloperidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of treatment-emergent adverse events as measured by the number of events', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar I Disorder', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients 18 to 65 years of age (inclusive)\n* Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria\n* Symptomatically stable within the past two months\n\nExclusion Criteria:\n\n* Exposure to any investigational medication, including placebo, in the past 60 days\n* Non-response to clozapine'}, 'identificationModule': {'nctId': 'NCT04127058', 'briefTitle': 'Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia', 'orgStudyIdInfo': {'id': 'VP-VYV-683-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CYP2D6 non-poor metabolizers', 'description': 'titrated up to 24 mg daily (12 mg b.i.d.)', 'interventionNames': ['Drug: Iloperidone']}, {'type': 'OTHER', 'label': 'CYP2D6 poor metabolizers', 'description': 'titrated up to 12 mg daily (6 mg b.i.d.)', 'interventionNames': ['Drug: Iloperidone']}], 'interventions': [{'name': 'Iloperidone', 'type': 'DRUG', 'otherNames': ['FANAPT®', 'VYV-683'], 'description': 'Oral Tablet', 'armGroupLabels': ['CYP2D6 non-poor metabolizers', 'CYP2D6 poor metabolizers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08009', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}