Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-08 @ 9:22 PM
Study NCT ID:
NCT04893395
Status:
WITHDRAWN
Last Update Posted:
2022-08-09
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Does not meet criteria for a clinical trial per IRB review.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-14', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized', 'timeFrame': 'At enrollment', 'description': 'A medication history will be conducted at enrollment to ensure patient meets criteria for enrollment. Patients will provide a saliva sample at this timepoint. The rate of pharmacogenomic variation will be calculated based on current medications at enrollment; however, the pharmacogenomic screening panel may take up to 6 weeks to return to the patient and investigator.'}], 'secondaryOutcomes': [{'measure': 'Rate of pharmacogenomic variation with actionable recommendations for all actionable medications', 'timeFrame': 'At enrollment'}, {'measure': 'Mental health disease state control/progression utilizing disease state-specific validated tools', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review', 'description': 'Validated, disease state-specific tools will be utilized to assess control or progression. Specifically, depression control will be assessed utilizing PHQ-9 as documented within the chart. This will be assessed via retrospective chart review.'}, {'measure': 'Medication-related costs', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review', 'description': 'Claims data will be used to assess medication-related costs at specific time points.'}, {'measure': 'Medication-related adverse events', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Patient reported medication adherence and reasons for non-adherence', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Patient reported reasons for non-adherence', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Number of pharmacogenomic recommendations made and accepted', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Type of pharmacogenomic recommendations made and accepted', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Number of non-pharmacogenomic recommendations made and accepted', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}, {'measure': 'Type of non-pharmacogenomic recommendations made and accepted', 'timeFrame': '3-, 6-, and 12-months post-recommendation via retrospective chart review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacogenetics', 'Depressive Disorder, Major', 'Medication Therapy Management']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 19 years\n2. Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine).\n3. Diagnosis of major depressive disorder (MDD)\n\nExclusion Criteria:\n\n1. Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration\n2. Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment)\n3. Individuals receiving mental health treatment/care from a non-VA facility\n4. Individuals who are terminally ill\n5. Inability to communicate in and/or understand English'}, 'identificationModule': {'nctId': 'NCT04893395', 'briefTitle': 'Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans', 'organization': {'class': 'OTHER', 'fullName': 'Auburn University'}, 'officialTitle': 'Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans', 'orgStudyIdInfo': {'id': 'TVA_IRBNetID_1614352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacogenomic Screening', 'description': 'Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.', 'interventionNames': ['Other: Pharmacogenomic Screening']}], 'interventions': [{'name': 'Pharmacogenomic Screening', 'type': 'OTHER', 'description': 'First telehealth appointment:\n\n1. Pharmacogenomics education and informed consent\n2. Medical history\n3. Sample collection\n\nSecond telehealth appointment:\n\n1. Results of pharmacogenomic testing\n2. Utility and limitations of pharmacogenomic testing\n3. Patient-specific potential impacts on current or future medication therapies\n4. Answering of patient questions\n5. Referral to mental health provider(s) for treatment-specific recommendations', 'armGroupLabels': ['Pharmacogenomic Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Tuscaloosa VAMC', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}], 'overallOfficials': [{'name': 'Kimberly B Lloyd, Pharm.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Auburn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auburn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tuscaloosa Veterans Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Courtney Watts Alexander', 'investigatorAffiliation': 'Auburn University'}}}}