Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-28 @ 5:14 PM
Study NCT ID:
NCT03232502
Status:
UNKNOWN
Last Update Posted:
2017-07-28
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenetics in Primary Care Psychotropics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D005820', 'term': 'Genetic Testing'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient oriented outcome1- Clinical Improvement', 'timeFrame': '6 months', 'description': 'Clinically significant improvement as noted by physician (Subjective and PHQ-9)'}, {'measure': 'Patient oriented outcome2- Adverse effects', 'timeFrame': '6 months', 'description': 'Number of patients with specific, common side effects (from medical chart)'}, {'measure': 'Patient oriented outcome3- Time to Improvement', 'timeFrame': 'Up to 6 months', 'description': 'Days to clinical improvement (from medical chart)'}, {'measure': 'Patient oriented outcome5- Visits', 'timeFrame': '6 months', 'description': 'Total number of visits to clinic with medication titration required (from medical chart)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Obsessive-Compulsive Disorder', 'Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18\n* Prescribed a drug of interest for the first time\n\nExclusion Criteria:\n\n* Previous pharmacogenetic testing available'}, 'identificationModule': {'nctId': 'NCT03232502', 'briefTitle': 'Pharmacogenetics in Primary Care Psychotropics', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Pharmacogenetics in Primary Care Psychotropics', 'orgStudyIdInfo': {'id': 'Pending1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Diagnostic Test: Pharmacogenetic testing']}], 'interventions': [{'name': 'Pharmacogenetic testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Basic pharmacogenetic panel', 'armGroupLabels': ['Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}