Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 10:08 PM
Study NCT ID:
NCT00053703
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2003-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
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'}, {'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D008972', 'term': 'Molindone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lsikich@med.unc.edu', 'phone': '919-972-9744', 'title': 'Linmarie Sikich, MD', 'organization': 'UNC Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The most significant weakness of this study was the sample size, which was sufficient only to detect large differences across the three treatments and limited our ability to identify predictors of response or adverse effects.'}}, 'adverseEventsModule': {'timeFrame': '8 weeks, Systematic events', 'eventGroups': [{'id': 'EG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks', 'otherNumAtRisk': 35, 'otherNumAffected': 26, 'seriousNumAtRisk': 35, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks', 'otherNumAtRisk': 41, 'otherNumAffected': 35, 'seriousNumAtRisk': 41, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks', 'otherNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual Irregularities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation/Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Psychiatric Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Thoughts (life-threatening)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'OG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.6', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '-23.7', 'spread': '25.5', 'groupId': 'OG001'}, {'value': '-27.0', 'spread': '17.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores \\> that 60 are considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'OG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '3.95', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '2.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'change in weight from baseline to week 8 in kg', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Barnes Akathisia Scale at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'OG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '3.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'OG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.9', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '-8.8', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in PANSS Negative Symptom Subscale at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'OG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '6.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index Change, kg/m2, at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'OG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '1.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'FG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'FG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'From February 2002 to May 2006, youth were screened at four academic sites: University of North Carolina at Chapel Hill, McLean Hospital and Cambridge Health Alliance at Harvard Medical School, University of Washington, and Case Western Reserve University.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks'}, {'id': 'BG001', 'title': 'Risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks'}, {'id': 'BG002', 'title': 'Molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.84', 'spread': '2.41', 'groupId': 'BG000'}, {'value': '14.54', 'spread': '2.38', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '2.4', 'groupId': 'BG002'}, {'value': '14.25', 'spread': '2.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'We are referring to the population of participants who had baseline assessment, took at least one dose of trial medication, and had at least one post-baseline assessment. There were 3 randomized subjects, on in each treatment group, who did not take at least one dose of study medication and are not included.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-07', 'studyFirstSubmitDate': '2003-02-04', 'resultsFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2003-02-04', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-07', 'studyFirstPostDateStruct': {'date': '2003-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores \\> that 60 are considered clinically significant.'}, {'measure': 'Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.', 'timeFrame': '8 weeks', 'description': 'The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.'}, {'measure': 'Change From Baseline in PANSS Negative Symptom Subscale at Week 8', 'timeFrame': '8 weeks', 'description': 'The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Weight at Week 8', 'timeFrame': '8 weeks', 'description': 'change in weight from baseline to week 8 in kg'}, {'measure': 'Change From Baseline in Barnes Akathisia Scale at Week 8', 'timeFrame': '8 weeks', 'description': 'Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.'}, {'measure': 'Change From Baseline in Body Mass Index Change, kg/m2, at Week 8', 'timeFrame': '8 weeks', 'description': 'Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psychotic Disorders', 'Schizophreniform Disorder'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '17667476', 'type': 'RESULT', 'citation': 'McCLELLAN J, Sikich L, Findling RL, Frazier JA, Vitiello B, Hlastala SA, Williams E, Ambler D, Hunt-Harrison T, Maloney AE, Ritz L, Anderson R, Hamer RM, Lieberman JA. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): rationale, design, and methods. J Am Acad Child Adolesc Psychiatry. 2007 Aug;46(8):969-978. doi: 10.1097/CHI.0b013e3180691779.'}, {'pmid': '17667477', 'type': 'RESULT', 'citation': 'Frazier JA, McCLELLAN J, Findling RL, Vitiello B, Anderson R, Zablotsky B, Williams E, McNAMARA NK, Jackson JA, Ritz L, Hlastala SA, Pierson L, Varley JA, Puglia M, Maloney AE, Ambler D, Hunt-Harrison T, Hamer RM, Noyes N, Lieberman JA, Sikich L. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): demographic and clinical characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Aug;46(8):979-988. doi: 10.1097/chi.0b013e31807083fd.'}, {'pmid': '20494268', 'type': 'RESULT', 'citation': 'Findling RL, Johnson JL, McClellan J, Frazier JA, Vitiello B, Hamer RM, Lieberman JA, Ritz L, McNamara NK, Lingler J, Hlastala S, Pierson L, Puglia M, Maloney AE, Kaufman EM, Noyes N, Sikich L. Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):583-94; quiz 632. doi: 10.1016/j.jaac.2010.03.013. Epub 2010 May 1.'}, {'pmid': '32633541', 'type': 'DERIVED', 'citation': 'Taylor JH, Appel S, Eli M, Alexander-Bloch A, Maayan L, Gur RE, Bloch MH. Time to Clinical Response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study. J Child Adolesc Psychopharmacol. 2021 Feb;31(1):46-52. doi: 10.1089/cap.2020.0030. Epub 2020 Jul 1.'}, {'pmid': '29920116', 'type': 'DERIVED', 'citation': 'Taylor JH, Jakubovski E, Gabriel D, Bloch MH. Predictors and Moderators of Antipsychotic-Related Weight Gain in the Treatment of Early-Onset Schizophrenia Spectrum Disorders Study. J Child Adolesc Psychopharmacol. 2018 Sep;28(7):474-484. doi: 10.1089/cap.2017.0147. Epub 2018 Jun 19.'}, {'pmid': '28595147', 'type': 'DERIVED', 'citation': 'Gabriel D, Jakubovski E, Taylor JH, Artukoglu BB, Bloch MH. Predictors of treatment response and drop out in the Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) study. Psychiatry Res. 2017 Sep;255:248-255. doi: 10.1016/j.psychres.2017.05.038. Epub 2017 May 30.'}, {'pmid': '22525956', 'type': 'DERIVED', 'citation': 'Frazier JA, Giuliano AJ, Johnson JL, Yakutis L, Youngstrom EA, Breiger D, Sikich L, Findling RL, McClellan J, Hamer RM, Vitiello B, Lieberman JA, Hooper SR. Neurocognitive outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders study. J Am Acad Child Adolesc Psychiatry. 2012 May;51(5):496-505. doi: 10.1016/j.jaac.2012.02.001. Epub 2012 Mar 13.'}, {'pmid': '18794207', 'type': 'DERIVED', 'citation': 'Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, Puglia M, Maloney AE, Michael E, De Jong S, Slifka K, Noyes N, Hlastala S, Pierson L, McNamara NK, Delporto-Bedoya D, Anderson R, Hamer RM, Lieberman JA. Double-blind comparison of first- and second-generation antipsychotics in early-onset schizophrenia and schizo-affective disorder: findings from the treatment of early-onset schizophrenia spectrum disorders (TEOSS) study. Am J Psychiatry. 2008 Nov;165(11):1420-31. doi: 10.1176/appi.ajp.2008.08050756. Epub 2008 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.', 'detailedDescription': 'Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active psychotic symptoms.\n\nParticipants are randomly assigned to receive risperidone (Risperdal), olanzapine (Zyprexa), or molindone (Moban) for 8 weeks. After 11/2005, no additional patients will be assigned to olanzapine treatment. Patients with significant improvement and without side effects continue maintenance therapy for another 44 weeks. Participants who show significant negative symptoms after 8 weeks may be started on a mood stabilizer or antidepressant. Weight gain, metabolic changes, neurocognition, functional outcome, psychotic symptoms, extrapyramidal side effects, and the ability to sustain effective therapy over time are assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms\n* Free of depot antipsychotic medication for at least 6 months. Oral antipsychotic medication at entry into the study is allowed, provided the participant has not had an adequate trial during the present episode of psychosis.\n* If taking antidepressant or mood stabilizing medication, stable dosing for at least 30 days prior to entry.\n* Good physical health\n\nExclusion Criteria:\n\n* Risperidone (RIS), olanzapine (OLA)\\*, or molindone (MOL) for 8 weeks or more during THIS episode, with 2 weeks at the maximal dose (6 mg/day of RIS, 20 mg/day of OLA, or 140 mg/day of MOL)\n* If using antidepressant and/or mood stabilizing medications, treatment for fewer than 30 days immediately before entry\n* Intolerance or nonresponse to RIS, OLA\\*, or MOL during any previous treatment\n* Bipolar affective disorder,post traumatic stress disorder, personality disorder, or psychosis not otherwise specified\n* Currently meeting Diagnostic and Statistical Manual version IV (DSM IV) criteria for major depression episode\n* DSM IV criteria for substance abuse or dependence with intention to continue illicit substance abuse\n* Endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics\n* Mental retardation\n* Risk of suicide or homicide that is not adequately controlled in the current setting\n* Pregnancy or refusal to practice contraception during the study\n\n"\\*" OLA exclusion not applicable after 11/2005'}, 'identificationModule': {'nctId': 'NCT00053703', 'acronym': 'TEOSS', 'briefTitle': 'Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)', 'nctIdAliases': ['NCT00030251', 'NCT00043290'], 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Treatment of Schizophrenia and Related Disorders in Children and Adolescents', 'orgStudyIdInfo': {'id': 'U01 MH 615218-01A'}, 'secondaryIdInfos': [{'id': 'U01MH062726', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062726', 'type': 'NIH'}, {'id': 'U01MH061355-01A1', 'link': 'https://reporter.nih.gov/quickSearch/U01MH061355-01A1', 'type': 'NIH'}, {'id': 'U01MH062726-01', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062726-01', 'type': 'NIH'}, {'id': 'U01MH061464-01A1', 'link': 'https://reporter.nih.gov/quickSearch/U01MH061464-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'olanzapine', 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks', 'interventionNames': ['Drug: Olanzapine (enrollment closed in this treatment)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'risperidone', 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks', 'interventionNames': ['Drug: Risperidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'molindone', 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks', 'interventionNames': ['Drug: Molindone']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': 'oral risperidone 0.5mg to 6mg daily for up to 52 weeks', 'armGroupLabels': ['risperidone']}, {'name': 'Olanzapine (enrollment closed in this treatment)', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'oral olanzapine 5-20mg per day for up to 52 weeks', 'armGroupLabels': ['olanzapine']}, {'name': 'Molindone', 'type': 'DRUG', 'otherNames': ['Moban'], 'description': 'oral molindone from 10-140mg/daily for up to 52 weeks', 'armGroupLabels': ['molindone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02155', 'city': 'Medford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cambridge Health Alliance', 'geoPoint': {'lat': 42.41843, 'lon': -71.10616}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Linmarie Sikich, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Linmarie Sikich, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}