Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-04-12 @ 8:26 AM
Study NCT ID:
NCT00429260
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2007-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-15', 'studyFirstSubmitDate': '2007-01-30', 'studyFirstSubmitQcDate': '2007-01-30', 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.'}], 'secondaryOutcomes': [{'measure': 'The main secondary endpoints are the change from baseline in the maximum number of post-baseline discontinuation-emergent signs or symptoms and the proportions of patients with any newly-occurring post-baseline discontinuation-emergent signs and symptoms'}]}, 'conditionsModule': {'keywords': ['depression', 'antidepressive agents'], 'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 100 mg once daily.\n\nThe secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria\n\nExclusion Criteria:\n\n* Total score of \\<22 on the Montgomery-Asberg Depression Rating Scale (MADRS).\n* Duration of the current depressive episode is less than 1 month or greater than 2 years.\n* Total score of \\<25 on the Mini Mental State Examination (elderly patients ≥65 years only).\n* Patients with a history or presence of bipolar disorders or psychotic disorders.\n* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 6 months except nicotine or caffeine dependence.\n* Patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.\n\nThe investigator will evaluate whether there are other reasons why a patient may not participate.'}, 'identificationModule': {'nctId': 'NCT00429260', 'briefTitle': 'A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 1-week, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Outpatients With Depression Who Completed 8 Weeks of Treatment With Saredutant 100 mg Once Daily', 'orgStudyIdInfo': {'id': 'SFY6577'}, 'secondaryIdInfos': [{'id': 'SR48968'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Saredutant', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19355', 'city': 'Malvern', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Administrative Office', 'geoPoint': {'lat': 40.03622, 'lon': -75.51381}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}