Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT00417118
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2006-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Eight-week Study to Evaluate the Efficacy and Safety 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'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 365}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-25', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2006-12-28', 'dispFirstSubmitQcDate': '2016-04-25', 'studyFirstSubmitQcDate': '2006-12-28', 'dispFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.', 'timeFrame': 'Baseline, Day 56'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the Clinical Global Impression Severity of Illness score.', 'timeFrame': 'Baseline, Day 56'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anxiety', 'clinical trials'], 'conditions': ['Generalized Anxiety']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy of a 100 mg dose 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': 'NCT00417118', 'briefTitle': 'An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Patients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'EFC5583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saredutant 100 mg', 'description': 'Saredutant 100 mg once daily in the morning for a maximum of 8 weeks', 'interventionNames': ['Drug: Saredutant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram 10 mg', 'description': 'Escitalopram 10 mg once daily in the morning for a maximum of 8 weeks', 'interventionNames': ['Drug: Escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for one week during the run in period and for a maximum of 8 weeks during the active period', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Saredutant', 'type': 'DRUG', 'description': 'oral administration (capsules)', 'armGroupLabels': ['Saredutant 100 mg']}, {'name': 'Escitalopram', 'type': 'DRUG', 'description': 'oral administration (capsules)', 'armGroupLabels': ['Escitalopram 10 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral administration (capsules)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}