Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT00330551
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2006-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keithn@ucla.edu', 'phone': '(310) 825-0036', 'title': 'Keith Nuechterlein, PhD', 'organization': 'University of California, Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This trial used oral risperidone as the comparator to allow a strong comparison between oral and long-acting injectable forms of the same drug. Generalization of results to other oral antipsychotic medications was not assessed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Long-acting Injectible Risperidone', 'description': 'Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.', 'otherNumAtRisk': 40, 'otherNumAffected': 11, 'seriousNumAtRisk': 40, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.', 'otherNumAtRisk': 43, 'otherNumAffected': 19, 'seriousNumAtRisk': 43, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'BMI increase from normal or overweight to Obese', 'notes': 'increase in BMI from normal or overweight to any Obese category', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lipid Increase', 'notes': 'Increase in LDL or Triglycerides from normal to high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tardive Dyskinesia', 'notes': 'New onset of mild symptoms of Tardive Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolactin related', 'notes': 'Symptoms related to prolactin levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'psychiatric hospitalization', 'notes': 'psychiatric hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.\n\nOral Risperidone: Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 't-test', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.77', 'ciLowerLimit': '0.483', 'ciUpperLimit': '1.058', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 't(80)=5.3, p\\<.001'}], 'paramType': 'MEAN', 'timeFrame': 'Measured weekly throughout study participation, averaged over study participation', 'description': '5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '11.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Occurrence after randomization and until end of study participation (up to 12 mos.)', 'description': 'Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to long-acting injectable or oral risperidone'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Returned to Work or School (SAS Work Section)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.\n\nOral Risperidone: Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.83', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from Baseline to Month 12', 'description': 'The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with data regarding return to work or school'}, {'type': 'PRIMARY', 'title': 'Number of Weeks Maintaining Work or School (SAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.20', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Cumulative total measured from Baseline to Month 12', 'description': 'Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with data on duration of work or school'}, {'type': 'PRIMARY', 'title': 'Change in Global Functioning Scale: Role', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 12', 'description': '10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months.', 'unitOfMeasure': 'Changes on a 10-point scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Global Functioning Scale: Role ratings at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.57', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and 12 months', 'description': 'The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome.', 'unitOfMeasure': 'Change score: change in T scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with MCCB Overall Composite scores at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Emotional Reactivity on Psychophysiological Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'timeFrame': 'Measured from Baseline to Month 12', 'description': 'Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were available because this part of the initial proposal was not funded.'}, {'type': 'SECONDARY', 'title': 'Retention in Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '307.6', 'spread': '108.3', 'groupId': 'OG000'}, {'value': '270.7', 'spread': '126.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 12 months', 'description': 'Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better retention in treatment.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to oral vs. long-acting injectable risperidone'}, {'type': 'SECONDARY', 'title': 'Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'OG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'classes': [{'categories': [{'measurements': [{'value': '.07', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '-.24', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.41', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': "Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.", 'unitOfMeasure': 'Change scores on 5-point rating scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with ratings at baseline and 12 months, with 6-month rating carried forward if no 12-month rating was completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'FG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'preAssignmentDetails': 'Of the 126 eligible and enrolled participants, 43 dropped out prior to the start of randomized treatment, resulting in 83 randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Long-acting Injectable Risperidone', 'description': 'Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nRisperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.'}, {'id': 'BG001', 'title': 'Oral Risperidone', 'description': 'Participants taking daily oral risperidone, plus group skills training and case management\n\nGroup Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.\n\nIndividual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.\n\nOral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '21.1', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '21.5', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2006-05-26', 'resultsFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2006-05-26', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-08', 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': 'Measured weekly throughout study participation, averaged over study participation', 'description': '5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation'}, {'measure': 'Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms', 'timeFrame': 'Occurrence after randomization and until end of study participation (up to 12 mos.)', 'description': 'Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.).'}, {'measure': 'Number of Participants Who Returned to Work or School (SAS Work Section)', 'timeFrame': 'Measured from Baseline to Month 12', 'description': 'The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment.'}, {'measure': 'Number of Weeks Maintaining Work or School (SAS)', 'timeFrame': 'Cumulative total measured from Baseline to Month 12', 'description': 'Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks.'}, {'measure': 'Change in Global Functioning Scale: Role', 'timeFrame': 'Measured at Baseline and Month 12', 'description': '10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months.'}], 'secondaryOutcomes': [{'measure': 'MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score', 'timeFrame': 'Measured at baseline and 12 months', 'description': 'The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome.'}, {'measure': 'Emotional Reactivity on Psychophysiological Measures', 'timeFrame': 'Measured from Baseline to Month 12', 'description': 'Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity.'}, {'measure': 'Retention in Treatment', 'timeFrame': 'From baseline to 12 months', 'description': 'Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better retention in treatment.'}, {'measure': 'Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R)', 'timeFrame': 'Baseline to 12 months', 'description': "Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizoaffective Disorder, Depressed Type', 'Schizophreniform Disorder', 'First-episode Schizophrenia', 'Injectable Risperidone'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '26107752', 'type': 'DERIVED', 'citation': 'Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):822-9. doi: 10.1001/jamapsychiatry.2015.0270.'}, {'pmid': '21767934', 'type': 'DERIVED', 'citation': 'Bartzokis G, Lu PH, Amar CP, Raven EP, Detore NR, Altshuler LL, Mintz J, Ventura J, Casaus LR, Luo JS, Subotnik KL, Nuechterlein KH. Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophr Res. 2011 Oct;132(1):35-41. doi: 10.1016/j.schres.2011.06.029. Epub 2011 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.', 'detailedDescription': 'Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer adverse side effects than older "typical" antipsychotics. Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.\n\nParticipants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks. Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder\n* First major episode of psychotic symptoms occurred within 2 years prior to study entry\n* Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia\n\nExclusion Criteria:\n\n* Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)\n* Mental retardation (e.g., premorbid IQ less than 70)\n* Significant alcohol or substance abuse within 6 months prior to study entry\n* Inability to complete research measures in English\n* Any condition that may make risperidone use medically inadvisable'}, 'identificationModule': {'nctId': 'NCT00330551', 'briefTitle': 'Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia', 'orgStudyIdInfo': {'id': 'P50MH066286', 'link': 'https://reporter.nih.gov/quickSearch/P50MH066286', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P50MH066286', 'link': 'https://reporter.nih.gov/quickSearch/P50MH066286', 'type': 'NIH'}, {'id': 'DATR A2-AISZ', 'type': 'REGISTRY', 'domain': 'World Health Organization ICTRP'}, {'id': 'Janssen RIS-NAP-4009', 'type': 'OTHER_GRANT', 'domain': 'Janssen Scientific Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-acting injectible risperidone', 'description': 'Participants who are randomly assigned to this arm will be administered the long-acting injectible form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.', 'interventionNames': ['Drug: Risperidone in Long-Acting Injectable Form (Consta)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral risperidone', 'description': 'Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.', 'interventionNames': ['Drug: Oral Risperidone']}], 'interventions': [{'name': 'Oral Risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': 'Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.', 'armGroupLabels': ['Oral risperidone']}, {'name': 'Risperidone in Long-Acting Injectable Form (Consta)', 'type': 'DRUG', 'otherNames': ['Risperdal Consta'], 'description': 'Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.', 'armGroupLabels': ['Long-acting injectible risperidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Semel Institute for Neuroscience and Human Behavior at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Keith H. Nuechterlein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, University of California, Los Angeles', 'investigatorFullName': 'Keith Nuechterlein, Ph.D.', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}