Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT01632267
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2012-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwinner@assurerxhealth.com', 'phone': '513-234-0510', 'title': 'Joel Winner, MD', 'organization': 'AssureRx'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Depression and Anxiety', 'description': 'Subjects with a primary diagnosis of depression or anxiety disorder.', 'otherNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Outpatient Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Depression and Anxiety', 'description': 'Subjects with a primary diagnosis of depression or anxiety disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '9.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the one year study window (April 1, 2010 to April 1, 2011)', 'description': 'Number of outpatient healthcare visits during study window', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Medical Absence Days', 'timeFrame': 'During the one year study window (April 1, 2010 to April 1, 2011)', 'description': 'Number of medical absence days during study window', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Disability Claims', 'timeFrame': 'During the one year study window (April 1, 2010 to April 1, 2011)', 'description': 'Number of disabiity claims during study window', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Depression and Anxiety', 'description': 'Subjects with a primary diagnosis of depression or anxiety disorder.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Depression and Anxiety', 'description': 'Subjects with a primary diagnosis of depression or anxiety disorder.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '11.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Buccal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-04', 'studyFirstSubmitDate': '2012-06-27', 'resultsFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-14', 'studyFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Outpatient Visits', 'timeFrame': 'During the one year study window (April 1, 2010 to April 1, 2011)', 'description': 'Number of outpatient healthcare visits during study window'}], 'secondaryOutcomes': [{'measure': 'Number of Medical Absence Days', 'timeFrame': 'During the one year study window (April 1, 2010 to April 1, 2011)', 'description': 'Number of medical absence days during study window'}, {'measure': 'Number of Disability Claims', 'timeFrame': 'During the one year study window (April 1, 2010 to April 1, 2011)', 'description': 'Number of disabiity claims during study window'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. The financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. The present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major Depressive Disorder\n* Dysthymic Disorder\n* Depressive Disorder NOS\n* Obsessive Compulsive Disorder (OCD)\n* Generalized Anxiety Disorder\n* Panic Disorder\n* Anxiety Disorder NOS\n* Post-Traumatic Stress Disorder (PTSD)\n* Social Phobia\n\nExclusion Criteria:\n\n* Bipolar Disorder\n* Schizophrenia\n* Schizoaffective Disorder\n* Previous pharmacogenomic testing'}, 'identificationModule': {'nctId': 'NCT01632267', 'acronym': 'UHS', 'briefTitle': 'Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Assurex Health Inc.'}, 'officialTitle': 'A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications', 'orgStudyIdInfo': {'id': '10003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depression and anxiety', 'description': 'Subjects with a primary diagnosis of depression or anxiety disorder.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Union Health Services', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Aida Spahic-Mihajlovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assurex Health Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}