Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 5:52 PM
Study NCT ID:
NCT06961968
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Withdrawal Study in Patients With 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to exacerbation of symptoms', 'timeFrame': 'Up to 52 weeks post-randomization', 'description': 'As measured by the time to first exacerbation of psychiatric symptoms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Antipsychotic Agents', 'Iloperidone', 'Long-Acting Injection', 'Randomized Withdrawal'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 18 to 65 years of age (inclusive)\n* Diagnosed with schizophrenia per DSM-5 criteria\n* In need of ongoing psychiatric treatment\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months'}, 'identificationModule': {'nctId': 'NCT06961968', 'briefTitle': 'Randomized Withdrawal Study in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection', 'orgStudyIdInfo': {'id': 'VP-VYV-683-3102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iloperidone', 'description': 'During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks.', 'interventionNames': ['Drug: iloperidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'iloperidone', 'type': 'DRUG', 'description': 'iloperidone LAI', 'armGroupLabels': ['iloperidone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92102', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanda Pharmaceuticals', 'role': 'CONTACT', 'phone': '202-734-3400'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanda Pharmaceuticals', 'role': 'CONTACT', 'phone': '202-734-3400'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'centralContacts': [{'name': 'Vanda Pharmaceuticals Inc.', 'role': 'CONTACT', 'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}