Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT00825058
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2009-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C076252', 'term': 'amibegron'}, {'id': 'C000722902', 'term': 'Amibegron hydrochloride'}, {'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'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': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-24', 'studyFirstSubmitDate': '2009-01-16', 'studyFirstSubmitQcDate': '2009-01-16', 'lastUpdatePostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline of the total score of the HAM-D 17 items.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'HAM-D subscores', 'timeFrame': '6 weeks'}, {'measure': 'HAM-D responders and remitters', 'timeFrame': '6 weeks'}, {'measure': 'HAM-A total score and subscores', 'timeFrame': '6 weeks'}, {'measure': 'MADRS total score', 'timeFrame': '6 weeks'}, {'measure': 'clinical global impression (CGI) severity and improvement scores', 'timeFrame': '6 weeks'}, {'measure': 'patient global impression (PGI) improvement score', 'timeFrame': '6 weeks'}, {'measure': 'social and occupational functioning assessment scale (SOFAS) score', 'timeFrame': '6 weeks'}, {'measure': 'clinical monitoring of adverse events (AEs)', 'timeFrame': '6 weeks'}, {'measure': 'laboratory parameters', 'timeFrame': '6 weeks'}, {'measure': 'electrocardiogram (ECG) parameters, change in vital signs and body weight', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression'], 'conditions': ['Major Depressive Disorders']}, 'descriptionModule': {'briefSummary': 'Primary objective :\n\n* To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode.\n\nSecondary objectives:\n\n* To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)\n* patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.\n* the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration'}, 'identificationModule': {'nctId': 'NCT00825058', 'briefTitle': 'Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.', 'orgStudyIdInfo': {'id': 'EFC5374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: amibegron (SR58611A)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: paroxetine']}], 'interventions': [{'name': 'amibegron (SR58611A)', 'type': 'DRUG', 'description': 'oral administration 2 X 350mg/day at 12 hours intervals', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral administration 12 hours intervals', 'armGroupLabels': ['2']}, {'name': 'paroxetine', 'type': 'DRUG', 'description': 'oral 20 mg/day', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Montenegro', 'country': 'Montenegro', 'facility': 'Sanofi-Aventis Administrative Office'}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}