Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT00061802
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2003-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
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': 'D018967', 'term': 'Risperidone'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-06', 'studyFirstSubmitDate': '2003-06-04', 'studyFirstSubmitQcDate': '2003-06-04', 'lastUpdatePostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.'}], 'secondaryOutcomes': [{'measure': 'Comparison of response rates based on proportion of patients in each study group that reach a predetermined percent decrease in psychotic symptom score at two weeks.'}]}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '17054789', 'type': 'RESULT', 'citation': 'Gharabawi GM, Greenspan A, Rupnow MF, Kosik-Gonzalez C, Bossie CA, Zhu Y, Kalali AH, Awad AG. Reduction in psychotic symptoms as a predictor of patient satisfaction with antipsychotic medication in schizophrenia: data from a randomized double-blind trial. BMC Psychiatry. 2006 Oct 20;6:45. doi: 10.1186/1471-244X-6-45.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder', 'detailedDescription': 'This study was intended to compare the efficacy and safety of risperidone, quetiapine, and placebo in the treatment of patients with acute exacerbations of schizophrenia or schizoaffective disorder. The primary tested hypothesis was a comparison of the efficacy of risperidone and quetiapine (active combined group) to placebo. Other a priori hypotheses tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine and placebo, and to evaluate the efficacy, safety, and cost of risperidone compared with quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or schizoaffective disorder.\n\nDuring the first phase of the study (15 days), patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day, depending on body weight. Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day, depending on body weight. Based on investigators determination of patient clinical response, patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight.\n\nDuring the second phase of the study (days 15 - 42), patients continue to take the dose of study medication taken in the first phase, but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic (defined as a certain minimum value on a clinical global severity scale.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Current diagnosis of an acute exacerbation of either schizophrenia or schizoaffective disorder'}, 'identificationModule': {'nctId': 'NCT00061802', 'briefTitle': 'Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Randomized, Double Blind Study to Evaluate the Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder', 'orgStudyIdInfo': {'id': 'CR002890'}}, 'armsInterventionsModule': {'interventions': [{'name': 'risperidone, quetiapine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Hoffman Est', 'state': 'Illinois', 'country': 'United States'}, {'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'city': 'Visakhapatnam', 'state': 'Missouri', 'country': 'United States'}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Aurangabad', 'country': 'India', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'city': 'New Delhi', 'country': 'India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Orange', 'country': 'India'}, {'city': 'San Diego', 'country': 'India'}, {'city': 'Lucknow', 'country': 'Romania'}, {'city': 'Richmond', 'country': 'Romania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}]}}}