Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-28 @ 12:29 AM
Study NCT ID:
NCT00097266
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2004-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Aripiprazole in Patients With Acute Bipolar Mania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 615}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2004-11-19', 'studyFirstSubmitQcDate': '2004-11-19', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in a mania rating scale at endpoint'}], 'secondaryOutcomes': [{'measure': 'Response rate and Clinical Global Impression scale at endpoint'}]}, 'conditionsModule': {'keywords': ['Bipolar Mania'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '19118324', 'type': 'BACKGROUND', 'citation': 'Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.'}, 'identificationModule': {'nctId': 'NCT00097266', 'briefTitle': 'Study of Aripiprazole in Patients With Acute Bipolar Mania', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder', 'orgStudyIdInfo': {'id': 'CN138-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: Haloperidol']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).', 'armGroupLabels': ['A']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'Tablets, oral, 15-30 mg, once daily, 12 weeks.', 'armGroupLabels': ['B']}, {'name': 'Haloperidol', 'type': 'DRUG', 'description': 'Capsule, oral, 5-15 mg, once daily, 12 weeks.', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 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