Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-25 @ 12:26 PM
Study NCT ID:
NCT01034995
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2009-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients 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': 'C502407', 'term': 'SSR125543'}, {'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-13', 'studyFirstSubmitDate': '2009-12-17', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in HAM-D depressed mood item', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in HAM-D responders (50% improvement)', 'timeFrame': '8 weeks'}, {'measure': 'Changes from baseline in the HAM-D core and factor scores', 'timeFrame': '8 weeks'}, {'measure': 'Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score', 'timeFrame': '8 weeks'}, {'measure': 'Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depression']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.\n\nSecondary Objectives:\n\n* To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder\n* To evaluate plasma concentrations of SSR125543', 'detailedDescription': 'This duration of this trial is 11 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).\n\nExclusion criteria:\n\n* Inpatient hospitalization at screening\n* Symptoms of depression present for \\<30 days or \\>2 years\n* Significant suicide risk\n* Mild depression as measured by standard clinical research scales\n* History of failure to respond to antidepressant treatment\n* Other psychiatric conditions that could obscure the results of the study\n* For women of child-bearing potential, the unwillingness to use highly effective means of birth control\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01034995', 'acronym': 'AGATE', 'briefTitle': 'A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'DFI5687'}, 'secondaryIdInfos': [{'id': '2009-010339-42', 'type': 'OTHER', 'domain': 'EMEA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSR125543 20 mg', 'description': '1 capsule of SSR125543 20 mg + 1 capsule of placebo', 'interventionNames': ['Drug: SSR125543']}, {'type': 'EXPERIMENTAL', 'label': 'SSR125543 50 mg', 'description': '1 capsule of SSR125543 50 mg + 1 capsule of placebo', 'interventionNames': ['Drug: SSR125543']}, {'type': 'EXPERIMENTAL', 'label': 'SSR125543 100 mg', 'description': '2 capsules of SSR125543 50 mg', 'interventionNames': ['Drug: SSR125543']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'escitalopram 10 mg', 'description': '1 capsule of escitalopram 10 mg + 1 capsule of placebo', 'interventionNames': ['Drug: escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '2 capsules of placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'SSR125543', 'type': 'DRUG', 'description': 'Pharmaceutical form: capsule\n\nRoute of administration: oral', 'armGroupLabels': ['SSR125543 100 mg', 'SSR125543 20 mg', 'SSR125543 50 mg']}, {'name': 'escitalopram', 'type': 'DRUG', 'description': 'Pharmaceutical form: encapsulated tablets\n\nRoute of administration: oral', 'armGroupLabels': ['escitalopram 10 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: capsule\n\nRoute of administration: oral', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1730', 'city': 'Asse', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Investigational Site Number 056002', 'geoPoint': {'lat': 50.91011, 'lon': 4.19836}}, {'zip': '1180', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Investigational Site Number 056003', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Investigational Site Number 056001', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'L7R 4E2', 'city': 'Burlington', 'country': 'Canada', 'facility': 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