Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT00073203
Status:
COMPLETED
Last Update Posted:
2009-08-28
First Post:
2003-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder
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': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 488}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2004-05', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2009-08-27', 'studyFirstSubmitDate': '2003-11-17', 'studyFirstSubmitQcDate': '2003-11-18', 'lastUpdatePostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-11-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder.\n\nApproximately 488 subjects will be involved in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up.\n* Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol.\n* The subject also needs to be an outpatient to participate in this study.'}, 'identificationModule': {'nctId': 'NCT00073203', 'briefTitle': 'A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A 6- Week, Randomized, Double-Blind, Parallel-Group, Active-and Placebo-Controlled Trial to Assess the Efficacy of R228060 in Adult Subjects With Major Depressive Disorder (MDD)', 'orgStudyIdInfo': {'id': 'CR004339'}}, 'armsInterventionsModule': {'interventions': [{'name': 'R228060', 'type': 'DRUG'}, {'name': 'Placebo and Paroxetine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08560', 'city': 'Titusville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'JJ PRD Research Center', 'geoPoint': {'lat': 40.30955, 'lon': -74.88044}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}}}}