Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-29 @ 7:19 AM
Study NCT ID:
NCT00734435
Status:
TERMINATED
Last Update Posted:
2012-11-29
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Sponsor Decision- Financial Considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2012-11-27', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2008-08-12', 'dispFirstSubmitQcDate': '2012-11-27', 'studyFirstSubmitQcDate': '2008-08-13', 'dispFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in total body weight', 'timeFrame': 'Baseline to Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizophreniform', 'schizoaffective disorder', 'Zyprexa', 'olanzapine'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects,18-55 years of age\n* Outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder\n* Body mass index (BMI) between 22-35 kg/m2 (inclusive)\n* Negative serum pregnancy test in women of child-bearing potential\n* If women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug\n* Subject requires a change in antipsychotic treatment and olanzapine is deemed by the Investigator to be a reasonable antipsychotic treatment choice\n* No clinically significant abnormality on ECG\n* No clinically significant laboratory abnormality\n* Negative urine drug screen\n* Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule\n* Must be able to read and understand English\n\nExclusion Criteria:\n\n* Diagnosis of substance dependence within the 6 months prior to randomization\n* diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization\n* Suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent\n* Presence of dementia or other organic brain syndrome\n* Serious or unstable medical illnesses\n* Known, uncorrected narrow-angle glaucoma\n* Diagnosis of eating disorder as defined by DSM-IV within 6 months prior to randomization\n* Require treatment with any typical or atypical antipsychotic in addition to olanzapine'}, 'identificationModule': {'nctId': 'NCT00734435', 'briefTitle': 'Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orexigen Therapeutics, Inc'}, 'officialTitle': 'A Proof of Concept, Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Study of Zonisamide Sustained Release (SR) 360 mg Versus Placebo in the Prevention of Weight Gain Associated With Olanzapine Therapy for Psychosis', 'orgStudyIdInfo': {'id': 'OZ-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Zonisamide SR 360 mg and olanzapine 10-20 mg daily', 'interventionNames': ['Drug: zonisamide SR plus olanzapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo and olanzapine 10-20 mg daily', 'interventionNames': ['Drug: Placebo plus olanzapine']}], 'interventions': [{'name': 'zonisamide SR plus olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)', 'armGroupLabels': ['1']}, {'name': 'Placebo plus olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCI Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92126', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'CNRI San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clincal Research Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34208', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'American Medical Research', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '46222', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Larue D. Carter Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '11223', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Medical Institute', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Alan Breier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larue D. Carter Hospital'}, {'name': 'Mohammed Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Medical Research'}, {'name': 'Gerald Maguire, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCI Medical Center'}, {'name': 'Zinoviy Benzar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brooklyn Medical Institute'}, {'name': 'Mohammed Bari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Synergy Research'}, {'name': 'Tran Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CNRI'}, {'name': 'Eduard Gfeller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Clinical Research Center, Maitland Florida'}, {'name': 'Andrew Cutler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Clinical Research Center, Bradenton Florida'}, {'name': 'Robert Riesenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Center for Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orexigen Therapeutics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}