Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-06 @ 4:45 AM
Study NCT ID:
NCT00090012
Status:
COMPLETED
Last Update Posted:
2007-11-06
First Post:
2004-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-05', 'studyFirstSubmitDate': '2004-08-18', 'studyFirstSubmitQcDate': '2004-08-20', 'lastUpdatePostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients'}, {'measure': 'with schizophrenia or schizoaffective disorder. Relapse is defined as the occurrence of at least one of the following three conditions:'}, {'measure': 'Hospitalization for psychiatric reasons after Visit 2, or'}, {'measure': '20% worsening on the Positive and Negative Syndrome Sale (PANSS) Total and an increase in level of care, as compared to Visit 2, or'}, {'measure': '20% worsening on the PANSS Total compared to Visit 2 and worsening of CGI-S by at least one level compared to Visit 2 and CGI-S level of at least 4 (moderately ill).'}], 'secondaryOutcomes': [{'measure': 'To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin'}, {'measure': 'To assess within and between group changes in weight, waist circumference, BMI, appetite, and prevalence of patients meeting criteria for the metabolic syndrome'}, {'measure': 'To assess within and between group changes in metabolic parameters (fasting glucose and lipids, and hemoglobin A1c) in a sub-group of patients with pre-existing diabetes prior to study entry'}, {'measure': 'To assess the effect of olanzapine versus quetiapine on time to discontinuation for any reason, or lack of efficacy or worsening of psychiatric syndromes'}, {'measure': 'To assess the efficacy of olanzapine versus quetiapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS and the Clinical Global Impression-Severity (CGI-S)'}, {'measure': 'Scale as well as by absolute score of CGI-I (Improvement Scale)'}, {'measure': 'To assess the efficacy of olanzapine versus quetiapine in improving depressive symptoms as measured by a mean change from baseline on the montgomery-Asberg Depression Rating Scale (MADRS)'}, {'measure': "To assess the efficacy of olanzapine versus quetiapine in improving patients' general well being and overall level of functioning as measured by the Short Form 36 Health Survey (SF-36), the Patient Global Impression (PGI)Scale,"}, {'measure': 'and the Global Assessment of Functioning (GAF) Scale'}, {'measure': "To assess patients' opinions on the treatment with olanzapine versus quetiapine as measured by the Drug Attitude Inventory (DAI-10) Scale"}, {'measure': 'To compare the utilization of medical resources between patients treated with olanzapine or quetiapine'}, {'measure': 'To assess the safety of olanzapine and quetiapine as determined by:'}, {'measure': 'Treatment-emergent adverse events'}, {'measure': 'Vital signs and fasting laboratory analytes'}, {'measure': 'Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)'}, {'measure': 'A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the primary objective respectively'}]}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine:\n\n* The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight.\n* The safety of olanzapine as compared to quetiapine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder\n* You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period\n\nExclusion Criteria:\n\n* You are a woman and are pregnant or breastfeeding\n* You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.)\n* You have a history of allergic reaction or intolerance to olanzapine or quetiapine"}, 'identificationModule': {'nctId': 'NCT00090012', 'briefTitle': 'Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder', 'orgStudyIdInfo': {'id': '8894'}, 'secondaryIdInfos': [{'id': 'F1D-US-HGLR'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Olanzapine', 'type': 'DRUG'}, {'name': 'Quetiapine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Granite City', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.70144, 'lon': -90.14872}}, {'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'city': 'Kenilworth', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.67649, 'lon': -74.2907}}, {'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Olean', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.07756, 'lon': -78.42974}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'city': 'Paoli', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.04205, 'lon': -75.47631}}, {'city': 'Conroe', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.31188, 'lon': -95.45605}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Call1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}