Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT00327834
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2006-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atomoxetine in the Treatment of Binge Eating Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Binge-eating Disorder']}, 'referencesModule': {'references': [{'pmid': '17388708', 'type': 'RESULT', 'citation': 'McElroy SL, Guerdjikova A, Kotwal R, Welge JA, Nelson EB, Lake KA, Keck PE Jr, Hudson JI. Atomoxetine in the treatment of binge-eating disorder: a randomized placebo-controlled trial. J Clin Psychiatry. 2007 Mar;68(3):390-8. doi: 10.4088/jcp.v68n0306.'}]}, 'descriptionModule': {'briefSummary': 'The specific aim of this study is to assess the efficacy and safety of atomoxetine compared with placebo in outpatients with binge eating disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will meet the DSM-IV criteria for a diagnosis of binge-eating disorder for at least the last 6 months\n* In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization\n\nExclusion Criteria:\n\n* Have concurrent symptoms of bulimia nervosa or anorexia nervosa\n* Women who are pregnant, lactating, or of child bearing potential who are not using adequate contraceptive measures\n* Patients who are displaying clinically significant suicidality or homicidality'}, 'identificationModule': {'nctId': 'NCT00327834', 'briefTitle': 'Atomoxetine in the Treatment of Binge Eating Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Lindner Center of HOPE'}, 'officialTitle': 'Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients', 'orgStudyIdInfo': {'id': 'B4Z-US-X009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'atomoxetine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267-0559', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Susan L: McElroy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lindner Center of HOPE', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Susan McElroy', 'oldOrganization': 'Lindner Center of HOPE'}}}}