Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT01284218
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2011-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23514}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2011-01-25', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause health care costs', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Health care costs: MDD related, mental health related', 'timeFrame': '12 months'}, {'measure': 'Health care resource utilization: All cause, MDD related, mental health related', 'timeFrame': '12 months'}, {'measure': 'Duration of index therapies', 'timeFrame': '12 months'}, {'measure': 'Medication possession ratio to evaluate adherence', 'timeFrame': '12 months'}, {'measure': 'Discontinuation of index therapies', 'timeFrame': '12 months'}, {'measure': 'Therapy switches to a non-index antidepressant or non-index augmentation therapy', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/home.aspx', 'label': 'BMS Clinical Trials Disclosure'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm'}]}, 'descriptionModule': {'briefSummary': 'To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Commercial health plan members', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008.\n* 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period).\n* ≥1 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period.\n* Age ≥18 years as of the year of the pre-index period.\n\nExclusion Criteria:\n\n* No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period.\n* No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods.'}, 'identificationModule': {'nctId': 'NCT01284218', 'briefTitle': 'Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)', 'orgStudyIdInfo': {'id': 'CN138-609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aripiprazole cohort'}, {'label': 'Other atypical cohort'}, {'label': 'Other antidepressant cohort'}, {'label': 'Mood stabilizer cohort'}, {'label': 'Stimulant cohort'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'i3 Innovus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}