Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00080327
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2004-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2004-03-26', 'studyFirstSubmitQcDate': '2004-03-29', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change at endpoint in schizophrenia rating scale'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Improvement scale at endpoint and time to response'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months'}, 'identificationModule': {'nctId': 'NCT00080327', 'briefTitle': 'Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia', 'orgStudyIdInfo': {'id': 'CN138-113 ST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'Tablets, Oral, 2mg, Once daily, 6 weeks.', 'armGroupLabels': ['1']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'Tablets, Oral, 5mg, Once daily, 6 weeks.', 'armGroupLabels': ['2']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'Tablets, Oral, 10mg, Once daily, 6 weeks.', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0mg, Once daily, 6 weeks.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wallingford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bristol-Meyers Squibb Call Center', 'geoPoint': {'lat': 41.45704, 'lon': -72.82316}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka America Pharmaceutical', 'class': 'INDUSTRY'}]}}}