Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 10:47 AM
Study NCT ID:
NCT00048594
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2002-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2003-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2002-11-04', 'studyFirstSubmitQcDate': '2002-11-04', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months', 'timeFrame': 'after 10 weeks of treatment and over 6-10 months'}], 'secondaryOutcomes': [{'measure': 'CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6.', 'timeFrame': 'Week 10 at Month 6'}]}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis Link'}]}, 'descriptionModule': {'briefSummary': 'A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.', 'detailedDescription': 'The duration of treatment is 20 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with Major Depressive Disorder'}, 'identificationModule': {'nctId': 'NCT00048594', 'briefTitle': 'Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '0869-065'}, 'secondaryIdInfos': [{'id': 'Formally-35MRB2'}, {'id': 'MK0869-065'}, {'id': '2006_405'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aprepitant', 'type': 'DRUG', 'otherNames': ['MK0869']}, {'name': 'Comparator: placebo (unspecified)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}