Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07483294
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebellum-based Imaging Neural Markers for Antipsychotic Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebellar-cortical functional connectivity', 'timeFrame': '2025-2029', 'description': 'To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response'}, {'measure': 'Cerebellar-cortical structural connectivity', 'timeFrame': '2025-2029', 'description': 'To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response'}], 'secondaryOutcomes': [{'measure': 'Cerebellar structural-functional integration', 'timeFrame': '2025-2029', 'description': 'To investigate the performance of integrated structural and functional connectivity in prediction of antipsychotic response'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychosis; Acute']}, 'descriptionModule': {'briefSummary': 'This study will investigate neural markers in the cerebellar-cortical circuitry that predict treatment response to antipsychotics in first-episode psychosis. A total of 120 patients diagnosed with a first-episode psychotic disorder will be recruited. All subjects receive naturalistic treatment with either risperidone or aripiprazole for 12 weeks, with dosage and titration followed by standard clinical care. A comprehensive clinical and neuroimaging assessments will be performed before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar disorder with psychosis, and major depressive disorder with psychosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar disorder with psychosis, and major depressive disorder with psychosis;\n* Current positive symptoms rated \\> 3 (moderate) on one or more of the BPRS psychosis items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;\n* At early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 8 weeks or less;\n* Age 16 to 40;\n* Competent to sign informed consent.\n\nExclusion Criteria:\n\n* Serious neurological or endocrine disorder or brain trauma;\n* Any medical condition which requires treatment with a medication with psychotropic effects;\n* Significant risk of suicidal or homicidal behavior;\n* Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;\n* Contraindications to antipsychotic monotherapy;\n* Contraindications to MR imaging (e.g. pacemaker);\n* Pregnancy by self report.'}, 'identificationModule': {'nctId': 'NCT07483294', 'acronym': 'CINEMA', 'briefTitle': 'Cerebellum-based Imaging Neural Markers for Antipsychotic Response', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis', 'orgStudyIdInfo': {'id': '25-0198'}, 'secondaryIdInfos': [{'id': 'R01MH137501', 'link': 'https://reporter.nih.gov/quickSearch/R01MH137501', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['Aripiprazole'], 'description': 'Naturalistic treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11004', 'city': 'Glen Oaks', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taylor Marzouk', 'role': 'CONTACT', 'email': 'tmarzouk@northwell.edu', 'phone': '718-470-8905'}], 'facility': 'Zucker Hillside Hospital', 'geoPoint': {'lat': 40.74705, 'lon': -73.71152}}], 'centralContacts': [{'name': 'Hengyi Cao', 'role': 'CONTACT', 'email': 'hcao2@northwell.edu', 'phone': '718-470-5913'}, {'name': 'Juan Gallego', 'role': 'CONTACT', 'email': 'jgallego@northwell.edu', 'phone': '718-470-4588'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}