Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01029769
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2009-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of 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': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D000077582', 'term': 'Amisulpride'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stefan.leucht@tum.de', 'phone': '+498941404200', 'title': 'Prof. Dr. Dr. Stefan Leucht', 'organization': 'Technische Universitaet Muenchen, Germany'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Patients with poor response to antipsychotic treatment in the past (treatment resistant patients) were not excluded by definition from study participation.'}}, 'adverseEventsModule': {'timeFrame': 'Entire 8 weeks of treatment', 'description': 'spontaneous reporting', 'eventGroups': [{'id': 'EG000', 'title': 'Period 1: Initital 2-week Treatment - Amisulpride Treated Patients', 'description': 'oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 36, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Period 1: Initital 2-week Treatment - Olanzapine Treated Patients', 'description': 'oral olanzapine 5mg to 20mg/d; preferably once daily, encapsulated for blinding', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 33, 'seriousNumAtRisk': 164, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Period 2: Extended 6-week Treatment - Early Responders', 'description': 'double blind continuation of treatment as in period 1; oral olanzapine 5mg to 20mg/d; OR oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 32, 'seriousNumAtRisk': 140, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Period 2: Extended 6-week Treatment - Early Non-responders Switched', 'description': 'double blind switch to the alternative drug not used in period 1; oral olanzapine 5mg to 20mg/d; OR oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 21, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Period 2: Extended 6-week Treatment - Early Non-responders Not Switched', 'description': 'double blind continuation of treatment as in period 1; oral olanzapine 5mg to 20mg/d; OR oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 7, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weight increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'prolongation of hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'life threatening event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'life threatening event', 'notes': 'suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'life threatening event', 'notes': 'lithium intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'death', 'notes': 'acute cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Non-responders Switched', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}, {'id': 'OG001', 'title': 'Early Non-responders Non-switched', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple imputation was performed separately for the switch and non-switch arms and the imputation model included the PANSS total score from all visits from phase II baseline (visit 2) onwards, remission at visit 7 and phase I arm allocation', 'groupDescription': 'Irrespective of the initially assigned antipsychotic treatment in period 1 of the trial (2-week-phase), the patients showing little improvement over the two weeks of treatment in period 1 now switched from the initial treatment in period 2 of the trial (6-week-phase) were grouped together as well as the patients non-switched from their initial treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'a logistic regression model with "remission" as the dependent variable and "switch" of treatment (yes/no) and PANSS-total score at visit 3 as independent variables was used. Multiple imputation (based upon 20 imputations, primary analysis), last observation carried forward and completers only analyses were performed.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Remission is defined as a maximum rating of 3 points (equals a severity rating of "mild") in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is \\>3 the remission status is "no" (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'please note that all patients, regardless of the medication received, were combined in these groups for the primary endpoint analysis solely depending on whether they have met the criteria for "early non-response" at the end of phase I of the trial; so the statistical analysis does not follow the treatment arms in phase I of the trial (patients received alternatively olanzapine or amisulpride, but both types of treatment appear in one and the same analysis group!)'}, {'type': 'SECONDARY', 'title': 'PANSS Total Score Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Non-responders Switched', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}, {'id': 'OG001', 'title': 'Ealy Non-responders Non-switched', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.8', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '-17.3', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "The Positive and Negative Syndrome Scale (Kay SR, Fiszbein A, Opler LA: The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bull 1987; 13:261-276) is a 30- item inventory assessing the absence or severity of schizophrenia symptoms across three subscales: positive symptoms (items P1-P7, including hallucinatory behavior, delusions, and conceptual disorganization), negative symptoms (items N1-N7, including blunted affect, social and emotional withdrawal, and lack of spontaneity), and general psychopathology symptoms (items G1-G16, including mannerisms and posturing, unusual thought content, and lack of insight). Each item is scored on a scale ranging from 1 (absent) to 7 (extreme), with item ratings incorporating the presence, effects of symptoms on an individuum's thinking, feeling or behaving as well as their severity. The min. sum rating is 30, the max. sum rating is 210.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Initial Olanzapin', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}, {'id': 'FG001', 'title': 'Initial Amisulpride', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}, {'id': 'FG002', 'title': 'Early Responders', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}, {'id': 'FG003', 'title': 'Early Non-responders Switched', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}, {'id': 'FG004', 'title': 'Ealy Non-responders Non-switched', 'description': 'Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding'}], 'periods': [{'title': 'Period 1: Initial 2-week Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Extended 6-week Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '17'}]}]}], 'preAssignmentDetails': 'The enrollment at baseline comprises the periods "initial olanzapine" and "initial amisulpride"; a re-randomisation was performed after 2 weeks of treatment; the patient numbers in the second phase of the trial must not be added to the overall participant number at baseline (other three groups all formed in phase II of the trial); NOTE that the groups "early responders", "early non-responders switched", "early non-responders non-switched" become active only in phase II of the trial, not before!!'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Period 1: Initital 2-week Treatment - Amisulpride', 'description': 'Baseline assessment of period 1 of all patients randomised to amisulpride flexible 200-800 mg/d double blind treatment'}, {'id': 'BG001', 'title': 'Period 1: Initital 2-week Treatment - Olanzapine', 'description': 'Baseline assessment of period 1 of all patients randomised to olanzapine flexible 5-20 mg/d double blind treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '39.8', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '327', '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': 'Germany', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Three hundred and twenty-seven patients were randomized in study phase I.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2009-12-09', 'resultsFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-02', 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders', 'timeFrame': '8 weeks', 'description': 'Remission is defined as a maximum rating of 3 points (equals a severity rating of "mild") in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is \\>3 the remission status is "no" (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating'}], 'secondaryOutcomes': [{'measure': 'PANSS Total Score Change', 'timeFrame': '8 weeks', 'description': "The Positive and Negative Syndrome Scale (Kay SR, Fiszbein A, Opler LA: The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bull 1987; 13:261-276) is a 30- item inventory assessing the absence or severity of schizophrenia symptoms across three subscales: positive symptoms (items P1-P7, including hallucinatory behavior, delusions, and conceptual disorganization), negative symptoms (items N1-N7, including blunted affect, social and emotional withdrawal, and lack of spontaneity), and general psychopathology symptoms (items G1-G16, including mannerisms and posturing, unusual thought content, and lack of insight). Each item is scored on a scale ranging from 1 (absent) to 7 (extreme), with item ratings incorporating the presence, effects of symptoms on an individuum's thinking, feeling or behaving as well as their severity. The min. sum rating is 30, the max. sum rating is 210."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder']}, 'descriptionModule': {'briefSummary': 'The main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic', 'detailedDescription': 'The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day.\n\nThose participants who have not responded to treatment at two weeks (PANSS improvement \\<25%) will be randomised to a 6 week double blind flexible dose phase:\n\n1. Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)\n2. Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients with Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV TR) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder\n* PANSS total score at baseline \\> 75, at least two PANSS psychosis items ≥ 4, Clinical Global Impression of severity score moderately ill or more (≥4)\n* Increase in the level of care (outpatient care to day clinic or inpatient care)\n\nExclusion Criteria:\n\n* contraindication to study drugs'}, 'identificationModule': {'nctId': 'NCT01029769', 'briefTitle': 'Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment', 'orgStudyIdInfo': {'id': '01KG0910'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'initial olanzapine', 'interventionNames': ['Drug: Olanzapine or amisulpride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'initial amisulpride', 'interventionNames': ['Drug: Olanzapine or amisulpride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'early responders', 'interventionNames': ['Drug: Olanzapine or amisulpride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'early non-responders switched', 'interventionNames': ['Drug: Olanzapine or amisulpride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ealy non-responders non-switched', 'interventionNames': ['Drug: Olanzapine or amisulpride']}], 'interventions': [{'name': 'Olanzapine or amisulpride', 'type': 'DRUG', 'description': 'Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding', 'armGroupLabels': ['ealy non-responders non-switched', 'early non-responders switched', 'early responders', 'initial amisulpride', 'initial olanzapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Stefan Leucht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universität München am Klinikum rechts der Isar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}