Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 2:54 PM
Study NCT ID:
NCT00629551
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
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': 'C073839', 'term': 'SR 48968'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-26', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2008-02-26', 'dispFirstSubmitQcDate': '2016-04-26', 'studyFirstSubmitQcDate': '2008-03-05', 'dispFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score', 'timeFrame': '8 weeks'}, {'measure': 'Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score', 'timeFrame': 'weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the Clinical Global Impression severity of illness score', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in the HAM-D depressed mood item scores', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Depression', 'Major Depressive Episode', 'Antidepressant'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with recurrent Major Depressive Disorder\n\nExclusion Criteria:\n\n* Symptoms of current depressive episode for less than 30 days or more than 2 years\n* Mild depression, as measured by standard clinical research scales\n* Significant suicide risk\n* Lack of sexual activity (including masturbation)\n* Other psychiatric conditions that would obscure the results of the study\n* History of failure to respond to antidepressant treatment\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00629551', 'acronym': 'COMPASS', 'briefTitle': 'An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'EFC10438'}, 'secondaryIdInfos': [{'id': 'EudraCT 2007-003863-31'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saredutant 100mg and Paroxetine 20 mg', 'description': 'combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks', 'interventionNames': ['Drug: saredutant (SR48968)', 'Drug: paroxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Saredutant 30mg and Paroxetine 20mg', 'description': 'combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks', 'interventionNames': ['Drug: saredutant (SR48968)', 'Drug: paroxetine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paroxetine 20 mg and saredutant placebo', 'description': 'paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks', 'interventionNames': ['Drug: paroxetine', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'saredutant (SR48968)', 'type': 'DRUG', 'description': 'oral administration,capsules', 'armGroupLabels': ['Saredutant 100mg and Paroxetine 20 mg', 'Saredutant 30mg and Paroxetine 20mg']}, {'name': 'paroxetine', 'type': 'DRUG', 'description': 'oral administration, capsules', 'armGroupLabels': ['Paroxetine 20 mg and saredutant placebo', 'Saredutant 100mg and Paroxetine 20 mg', 'Saredutant 30mg and Paroxetine 20mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral administration, capsules', 'armGroupLabels': ['Paroxetine 20 mg and saredutant placebo', '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': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}