Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 3:36 AM
Study NCT ID:
NCT00390533
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2006-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C073839', 'term': 'SR 48968'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-25', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2006-10-19', 'dispFirstSubmitQcDate': '2016-04-25', 'studyFirstSubmitQcDate': '2006-10-19', 'dispFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.', 'timeFrame': '56 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.', 'timeFrame': '56 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anxiety', 'clinical trials'], 'conditions': ['Generalized Anxiety']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.\n\nExclusion Criteria:\n\n* Total score of less than 22 on the HAM-A.\n* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.\n* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.\n* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.\n* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.\n\nThe investigator will evaluate whether there are other reasons why a patient may not participate.'}, 'identificationModule': {'nctId': 'NCT00390533', 'briefTitle': 'An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'EFC5582'}, 'secondaryIdInfos': [{'id': 'SR48968'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saredutant 30 mg', 'description': 'Saredutant 30 mg once daily for a maximum of 8 weeks', 'interventionNames': ['Drug: Saredutant']}, {'type': 'EXPERIMENTAL', 'label': 'Saredutant 100 mg', 'description': 'Saredutant 100 mg once daily for a maximum of 8 weeks', 'interventionNames': ['Drug: Saredutant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Saredutant', 'type': 'DRUG', 'description': 'oral administration (capsules)', 'armGroupLabels': ['Saredutant 100 mg', 'Saredutant 30 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral administration (capsules)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Macquarie Park', 'country': 'Australia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}