Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-25 @ 1:45 PM
Study NCT ID:
NCT00862992
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2009-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
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'seriousNumAtRisk': 10, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cariprazine 12.5 mg', 'otherNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 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'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 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0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nail injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood bilirubin increased', 'stats': 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{'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neuroleptic malignant syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Event and Adverse Drug Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'title': 'Number of Participants With Adverse event', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Number of Participants With Adverse drug Reaction', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'title': 'Unchanged MP-214', 'categories': [{'measurements': [{'value': '9.19', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '19.43', 'spread': '4.80', 'groupId': 'OG001'}, {'value': '36.39', 'spread': '8.53', 'groupId': 'OG002'}]}]}, {'title': 'M7 (desmethyl cariprazine)', 'categories': [{'measurements': [{'value': '3.14', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '11.37', 'spread': '3.00', 'groupId': 'OG002'}]}]}, {'title': 'M6 (didesmethyl cariprazine)', 'categories': [{'measurements': [{'value': '13.79', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '28.08', 'spread': '14.52', 'groupId': 'OG001'}, {'value': '54.99', 'spread': '14.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'title': 'Unchanged MP-214', 'categories': [{'measurements': [{'value': '3.71', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '3.22', 'spread': '0.45', 'groupId': 'OG002'}]}]}, {'title': 'M7 (desmethyl cariprazine)', 'categories': [{'measurements': [{'value': '5.25', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '4.36', 'spread': '1.80', 'groupId': 'OG002'}]}]}, {'title': 'M6 (didesmethyl cariprazine)', 'categories': [{'measurements': [{'value': '4.79', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '2.14', 'groupId': 'OG001'}, {'value': '5.22', 'spread': '2.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'title': 'Unchanged MP-214', 'categories': [{'measurements': [{'value': '298.36', 'spread': '128.04', 'groupId': 'OG000'}, {'value': '522.38', 'spread': '194.61', 'groupId': 'OG001'}, {'value': '1017.96', 'spread': '419.24', 'groupId': 'OG002'}]}]}, {'title': 'M7 (desmethyl cariprazine)', 'categories': [{'measurements': [{'value': '135.25', 'spread': '64.80', 'groupId': 'OG000'}, {'value': '232.38', 'spread': '113.31', 'groupId': 'OG001'}, {'value': '437.64', 'spread': '131.76', 'groupId': 'OG002'}]}]}, {'title': 'M6 (didesmethyl cariprazine)', 'categories': [{'measurements': [{'value': '1884.24', 'spread': '785.73', 'groupId': 'OG000'}, {'value': '3397.12', 'spread': '2395.44', 'groupId': 'OG001'}, {'value': '5950.73', 'spread': '1928.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '10.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, and on Day 14 or a last observation carried forward (LOCF)', 'description': 'PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, and on Day 14 or a last observation carried forward (LOCF)', 'description': "CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine 3 mg'}, {'id': 'OG001', 'title': 'Cariprazine 6 mg'}, {'id': 'OG002', 'title': 'Cariprazine 12.5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'on Day 14 or a last observation carried forward (LOCF)', 'description': "CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cariprazine 3 mg'}, {'id': 'FG001', 'title': 'Cariprazine 6 mg'}, {'id': 'FG002', 'title': 'Cariprazine 12.5 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cariprazine 3 mg'}, {'id': 'BG001', 'title': 'Cariprazine 6 mg'}, {'id': 'BG002', 'title': 'Cariprazine 12.5 mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '>=18 and =<30 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': '>=31 and =<40 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': '>=41 and =<55 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': '>55 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2009-03-15', 'resultsFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2009-03-15', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-08', 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)', 'timeFrame': 'at baseline, and on Day 14 or a last observation carried forward (LOCF)', 'description': 'PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.'}, {'measure': 'Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)', 'timeFrame': 'at baseline, and on Day 14 or a last observation carried forward (LOCF)', 'description': "CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill)."}, {'measure': 'The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)', 'timeFrame': 'on Day 14 or a last observation carried forward (LOCF)', 'description': "CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse)."}], 'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Event and Adverse Drug Reaction', 'timeFrame': 'Up to 7 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14', 'timeFrame': 'Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.'}, {'measure': 'Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14', 'timeFrame': 'Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14', 'timeFrame': 'Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'antipsychotics', 'dopamine D3/D2 antagonist'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients meeting DSM-IV-TR criteria for schizophrenia\n* PANSS total score \\<= 120 during the observation period\n* Patients who have been treated with oral antipsychotics within 4 weeks before informed consent\n* Patients whose consent is obtained from themselves in written form\n\nExclusion Criteria:\n\n* Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR\n* History of drug or alcohol abuse\n* Concurrent Parkinson\'s disease\n* History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder\n* Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values\n* Current cataract during the observation period\n* History of shock or anaphylactoid symptoms to drugs\n\nThe information is not intended to contain all considerations relevant to a patient\'s potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT00862992', 'briefTitle': 'Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)', 'orgStudyIdInfo': {'id': 'A002-A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Cariprazine 3 mg']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Cariprazine 6 mg']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Cariprazine 12.5 mg']}], 'interventions': [{'name': 'Cariprazine 3 mg', 'type': 'DRUG', 'otherNames': ['Cariprazine(INN)', 'RGH-188'], 'armGroupLabels': ['1']}, {'name': 'Cariprazine 6 mg', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Cariprazine 12.5 mg', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kure', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hoyu Hospital', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}], 'overallOfficials': [{'name': 'Teruhiko Higuchi, President', 'role': 'STUDY_CHAIR', 'affiliation': 'National Center of Neurology and Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}