Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-30 @ 8:23 AM
Study NCT ID:
NCT00439634
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2007-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523652', 'term': 'AVE1625'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 873}}, 'statusModule': {'whyStopped': 'Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-18', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2007-02-22', 'dispFirstSubmitQcDate': '2016-04-18', 'studyFirstSubmitQcDate': '2007-02-22', 'dispFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the MATRICS Cognitive Battery composite standardized score', 'timeFrame': 'at week 24'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the UPSA2 total score', 'timeFrame': 'at week 24'}, {'measure': 'Additional scales used for schizophrenia', 'timeFrame': 'at week 24'}, {'measure': 'Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events', 'timeFrame': 'study period'}]}, 'conditionsModule': {'keywords': ['psychometrics', 'schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '28433500', 'type': 'DERIVED', 'citation': 'Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia.\n\nThe main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients.\n\nThe secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called University of California San Diego Performance-based Skills Assessment 2 (UPSA2) and to assess the safety of the compound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with diagnosis of schizophrenia (diagnosed ≤ 35 years of age).\n* Current treatment consisting exclusively of olanzapine, risperidone/paliperidone, quetiapine or aripiprazole monotherapy for at least 2 months.\n\nExclusion Criteria:\n\n* Inpatient hospitalization within past 3 months.\n* Residence at the current address \\< 3 months due to any instability in the disease.\n* Presence of depressive symptoms.\n* Past history of clinically significant violent behavior.\n* Substance dependence or abuse.\n* Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.\n\nThe investigator will evaluate whether there are other reasons why a patient may not participate.'}, 'identificationModule': {'nctId': 'NCT00439634', 'acronym': 'CONNECT', 'briefTitle': 'Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of 3 Oral Doses of AVE1625 and Placebo on Top of Either Olanzapine, Risperidone/Paliperidone, Quetiapine or Aripiprazole in the Treatment of Cognitive Impairment in Schizophrenia.', 'orgStudyIdInfo': {'id': 'DRI6726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AVE1625 dose level 1', 'interventionNames': ['Drug: AVE1625']}, {'type': 'EXPERIMENTAL', 'label': 'AVE1625 dose level 2', 'interventionNames': ['Drug: AVE1625']}, {'type': 'EXPERIMENTAL', 'label': 'AVE1625 dose level 3', 'interventionNames': ['Drug: AVE1625']}], 'interventions': [{'name': 'AVE1625', 'type': 'DRUG', 'otherNames': ['Drinabant'], 'description': 'oral administration', 'armGroupLabels': ['AVE1625 dose level 1', 'AVE1625 dose level 2', 'AVE1625 dose level 3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral administration', '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': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}