Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
Study NCT ID:
NCT00063206
Status:
COMPLETED
Last Update Posted:
2009-08-19
First Post:
2003-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-18', 'studyFirstSubmitDate': '2003-06-23', 'studyFirstSubmitQcDate': '2003-06-24', 'lastUpdatePostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Depressive Disorder, Major', 'Depression, Involutional'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '18052559', 'type': 'DERIVED', 'citation': 'Liebowitz MR, Yeung PP, Entsuah R. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder. J Clin Psychiatry. 2007 Nov;68(11):1663-72. doi: 10.4088/jcp.v68n1105.'}]}, 'descriptionModule': {'briefSummary': 'Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.\n\nSecondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item \\[HAM-D\\<sub\\>17\\</sub\\>\\] \\< 7) versus those subjects receiving placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a primary diagnosis of major depressive disorder (MDD)\n* Depressive symptoms for at least 30 days prior to the screening visit\n* Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D\\<sub\\>17\\</sub\\>)\n\nExclusion Criteria:\n\n* Treatment with DVS-233 SR at any time in the past\n* Treatment with venlafaxine (immediate release \\[IR\\] or extended release \\[ER\\]) within 90 days of study day 1\n* Known hypersensitivity to venlafaxine (IR or ER)'}, 'identificationModule': {'nctId': 'NCT00063206', 'briefTitle': 'Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '3151A1-304'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DVS-233 SR', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}