Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT00169702
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Weight Management Program During Treatment With Olanzapine
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-28', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in mean weight gain', 'timeFrame': 'November 2007'}], 'secondaryOutcomes': [{'measure': 'changes in waist circumference, blood pressure, blood lipids, fasting glucose', 'timeFrame': 'November 2007'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia, weight management programme'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '12660797', 'type': 'BACKGROUND', 'citation': 'Hauner H, Rohrig K, Hebebrand J, Skurk T. No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 2003 Mar;8(3):258-9. doi: 10.1038/sj.mp.4001246. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study is a prospective, randomized, open-label study.', 'detailedDescription': 'The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia\n* Ages between 18 and 65\n* Informed consent\n* Weight gain of at least 1.5 kg in the first 4 weeks\n* A sufficient understanding to participate adequately in the weight management program\n* Patients must agree to cooperate with all tests and examinations required by the protocol.\n* Each patient must understand the nature of the study and must sign an informed consent document.\n\nExclusion Criteria:\n\n* Serious, unstable somatic illnesses\n* Illnesses associated with weight gain including renal and endocrine diseases\n* Weight change greater than 3 kg in the preceding three months\n* Weight gain less than 1.5 kg in the first 4 weeks'}, 'identificationModule': {'nctId': 'NCT00169702', 'briefTitle': 'The Effect of a Weight Management Program During Treatment With Olanzapine', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study', 'orgStudyIdInfo': {'id': 'F1D-SB-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard', 'description': 'standard information', 'interventionNames': ['Behavioral: weight management program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.', 'interventionNames': ['Behavioral: weight management program']}], 'interventions': [{'name': 'weight management program', 'type': 'BEHAVIORAL', 'description': '12 sessions, psychoeducation', 'armGroupLabels': ['Intervention', 'Standard']}, {'name': 'weight management program', 'type': 'BEHAVIORAL', 'description': '2 weekly, 12 sessions, psychoeducational weight management', 'armGroupLabels': ['Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40629', 'city': 'Düsseldorf', 'state': 'Rhineland State', 'country': 'Germany', 'facility': 'Heinrich-Heine-University, Rhineland State Clinics Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Joachim Cordes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany'}, {'name': 'Ansgar Klimke, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Psychiatry, Offenbach'}, {'name': 'Hans Hauner, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University of Munic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Else Kröner-Fresenius-Centre for Nutritional Medicine', 'class': 'UNKNOWN'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Cordes, Joachim', 'oldOrganization': 'Heinrich-Heine University'}}}}