Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01108393
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Y-BOCS total score', 'timeFrame': '16 weeks', 'description': 'Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.'}], 'secondaryOutcomes': [{'measure': 'NIMH-OC score', 'timeFrame': '16 weeks', 'description': 'National Institute for Mental Health- Obsessive Compulsive scale (NIMH-OC) Total Score. This scale measures the severity of obsessive and compulsive symptoms from baseline to week 16.'}, {'measure': 'MADRS total score', 'timeFrame': '16 weeks', 'description': 'Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obsessive Compulsive Disorder', 'Agomelatine'], 'conditions': ['Obsessive Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),\n* Y-BOCS total score ≥ 20,\n* duration of OCD symptoms of at least one year.\n\nExclusion Criteria:\n\n* Bipolar disorder, Schizophrenic or Psychotic Disorder\n* Severe or uncontrolled organic diseases\n* Neurological disorder\n* Women of childbearing potential who are not using effective contraception'}, 'identificationModule': {'nctId': 'NCT01108393', 'briefTitle': 'Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier'}, 'officialTitle': 'Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/Day After 8 Weeks of Treatment) Given Orally During 16 Weeks in Patients With Obsessive-Compulsive Disorder. A Randomised, Double-blind, Placebo-controlled, Parallel Groups, International Study', 'orgStudyIdInfo': {'id': 'CL2-20098-072'}, 'secondaryIdInfos': [{'id': '2009-016713-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Agomelatine A', 'interventionNames': ['Drug: Agomelatine A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Agomelatine A', 'type': 'DRUG', 'description': 'Agomelatine 25 mg film-coated tablet\n\nAgomelatine 2x25mg film-coated tablet', 'armGroupLabels': ['Agomelatine A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Department of Psychiatry Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Joseph Zohar, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry Chaim Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicaltrials.servier.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After Marketing Authorisation in EEA or US if the study is used for the approval.', 'ipdSharing': 'YES', 'description': 'Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).\n\nThey can ask all interventional clinical studies in patients:\n\n* submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).\n* Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.', 'accessCriteria': 'Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}