Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-29 @ 6:10 AM
Study NCT ID:
NCT03817502
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) 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': 'C533287', 'term': 'cariprazine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in PANSS total score at Week 6', 'timeFrame': 'Baseline to Week 6', 'description': 'The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-5 primary diagnosis of schizophrenia.\n* Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.\n* PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).\n* CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).\n\nExclusion Criteria:\n\n* Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition\n* Diagnosis of intellectual disability (IQ \\< 70).\n* Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.'}, 'identificationModule': {'nctId': 'NCT03817502', 'briefTitle': 'Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gedeon Richter Plc.'}, 'officialTitle': 'A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia', 'orgStudyIdInfo': {'id': 'RGH-MD-20'}, 'secondaryIdInfos': [{'id': '2018-004006-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cariprazine 1.5 mg/d', 'description': 'Cariprazine capsules, oral administration, once daily.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine 4.5 mg/d', 'description': 'Cariprazine capsules, oral administration, once daily.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'description': 'Cariprazine capsules, oral administration, once daily.', 'armGroupLabels': ['Cariprazine 1.5 mg/d', 'Cariprazine 4.5 mg/d']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules, oral administration, once daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90230', 'city': 'Culver City', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'ProScience Research Group', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Atlanta Behavioral Research, LLC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48302', 'city': 'Bloomfield Hills', 'state': 'Michigan', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Bloomfield Hills MI', 'geoPoint': {'lat': 42.58364, 'lon': -83.24549}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'status': 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Acad. O.I. Yushchenko"', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'centralContacts': [{'name': 'Balázs Lázár', 'role': 'CONTACT', 'email': 'RA.ctaRichter@richter.hu', 'phone': '+36 1 432 6437'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.', 'ipdSharing': 'YES', 'description': 'Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.', 'accessCriteria': 'To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gedeon Richter Plc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}