Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00178932
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. .', 'timeFrame': 'single visit'}], 'secondaryOutcomes': [{'measure': 'We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample', 'timeFrame': 'single visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder', 'Major Depression']}, 'descriptionModule': {'briefSummary': 'The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with the diagnoses of schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features, or volunteers with no history of a psychotic disorder.\n\nExclusion Criteria:\n\nPatients with DSM-IV diagnoses other than schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features.'}, 'identificationModule': {'nctId': 'NCT00178932', 'briefTitle': 'Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors', 'orgStudyIdInfo': {'id': '9132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Outcome in schizophrenia with certain antipsychotic', 'description': 'clozapine', 'interventionNames': ['Procedure: genetic analysis', 'Procedure: genetic assay']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Outcome in schizophrenia with other Antipsychotics', 'description': 'Other Antipsychotics', 'interventionNames': ['Procedure: genetic analysis', 'Procedure: genetic assay']}], 'interventions': [{'name': 'genetic analysis', 'type': 'PROCEDURE', 'description': "genetic assay of blood sample drawn with patient's consent", 'armGroupLabels': ['1 Outcome in schizophrenia with certain antipsychotic', '2 Outcome in schizophrenia with other Antipsychotics']}, {'name': 'genetic assay', 'type': 'PROCEDURE', 'description': "genetic assay of blood sample drawn with patient's consent", 'armGroupLabels': ['1 Outcome in schizophrenia with certain antipsychotic', '2 Outcome in schizophrenia with other Antipsychotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Psychiatric Hospital at Vanderbilt', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Herbert Y Meltzer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}