Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 5:53 AM
Study NCT ID:
NCT00723060
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2008-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement 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'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2008-07-24', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference of Y-BOCS score average from baseline to 16-week', 'timeFrame': 'baseline and16-week'}], 'secondaryOutcomes': [{'measure': '1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A', 'timeFrame': 'every 2 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obsessive Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).\n\nOVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S \\& -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Man or woman, aged 18 to 65 years, outpatient\n2. Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months\n3. Severity: Y-BOCS score of \\>= 20 at screening and baseline\n4. No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening\n5. Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.\n\nExclusion Criteria:\n\n1. primary active DSM-IV axis I diagnosis other than OCD\n2. History of substance, including alcohol, dependence and psychotic symptoms\n3. Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of \\>17 at screening or baseline\n4. Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity\n5. History of no response to escitalopram or citalopram treatment\n6. History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening\n7. Women who are pregnant, planning to become pregnant, or breast-feeding\n8. Ongoing cognitive behavior therapy (CBT) of OCD\n9. Hoarding or collecting type\n10. Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)'}, 'identificationModule': {'nctId': 'NCT00723060', 'briefTitle': 'Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder (Randomized, Double-blind, Multi-center Study)', 'orgStudyIdInfo': {'id': '11769A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'escitalopram high dose group', 'interventionNames': ['Drug: escitalopram']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'escitalopram conventional group', 'interventionNames': ['Drug: escitalopram']}], 'interventions': [{'name': 'escitalopram', 'type': 'DRUG', 'description': 'escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jun Soo Kwon, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seoul National University Hospital', 'oldOrganization': 'Seoul National University Hospital'}}}}