Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05368558
Status:
TERMINATED
Last Update Posted:
2025-10-20
First Post:
2022-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.', 'description': 'In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal modal (most frequent) daily dose during the 18-week BEP.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal modal (most frequent) daily dose during the 18-week BEP.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal (most frequent) daily dose during the 18-week BEP.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'SF DBP Placebo', 'description': 'Safety Follow up (SF) for DBP Placebo participants.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'SF DBP Cariprazine 3 mg', 'description': 'SF for DBP Cariprazine 3 mg participants.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'SF DBP Cariprazine 6 mg', 'description': 'SF for DBP Cariprazine 6 mg participants.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'SF BEP Cariprazine 1.5 mg', 'description': 'SF for BEP Cariprazine 1.5 mg participants.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'SF BEP Cariprazine 3 mg', 'description': 'SF for BEP Cariprazine 3 mg participants.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'SF BEP Cariprazine 6 mg', 'description': 'SF for BEP Cariprazine 6 mg participants.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'IRIDOCYCLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'DENTAL CARIES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'HAEMORRHOIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, 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'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'FEELING ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 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{'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'SCHIZOPHRENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population includes all randomized participants who receive at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.2', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '10.38', 'groupId': 'OG001'}, {'value': '-30.2', 'spread': '17.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '23.1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.0', 'ciLowerLimit': '-28.7', 'ciUpperLimit': '-1.4', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in CGI-S Score From Baseline (Wk 0) to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.3', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': "Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '3.35', 'groupId': 'OG001'}, {'value': '-8.7', 'spread': '4.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '7.5', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '0.0', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '9.20', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '8.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '9.7', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.3', 'ciLowerLimit': '-18.5', 'ciUpperLimit': '-4.1', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '-8.1', 'spread': '5.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '7.5', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '-0.4', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'OG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'OG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.78', 'groupId': 'OG001'}, {'value': '-9.1', 'spread': '6.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '7.7', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '-0.3', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.'}, {'id': 'OG001', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.'}, {'id': 'OG002', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.'}], 'classes': [{'title': 'Baseline (Wk 0) to Week 24', 'categories': [{'measurements': [{'value': '-19.2', 'spread': '19.52', 'groupId': 'OG000'}, {'value': '-19.3', 'spread': '30.09', 'groupId': 'OG001'}, {'value': '-22.5', 'spread': '25.16', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 to Week 24', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '16.05', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '4.58', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '17.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.'}, {'id': 'OG001', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.'}, {'id': 'OG002', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.'}], 'classes': [{'title': 'Baseline (Wk 0) to Week 24', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.82', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 to Week 24', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': "Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.'}, {'id': 'OG001', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.'}, {'id': 'OG002', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.'}], 'classes': [{'title': 'Baseline (Wk 0) to Week 24', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '7.51', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '6.60', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 to Week 24', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '6.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.'}, {'id': 'OG001', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.'}, {'id': 'OG002', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.'}], 'classes': [{'title': 'Baseline (Wk 0) to Week 24', 'categories': [{'measurements': [{'value': '-11.6', 'spread': '13.52', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '14.00', 'groupId': 'OG001'}, {'value': '-13.3', 'spread': '20.19', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 to Week 24', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.51', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '11.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.'}, {'id': 'OG001', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.'}, {'id': 'OG002', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.'}], 'classes': [{'title': 'Baseline (Wk 0) to Week 24', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '6.24', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '9.64', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 to Week 24', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '4.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.'}, {'id': 'OG001', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.'}, {'id': 'OG002', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.'}], 'classes': [{'title': 'Baseline (Wk 0) to Week 24', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '9.29', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '9.76', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 to Week 24', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '4.16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6-week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'FG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'FG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'FG003', 'title': 'BEP Cariprazine 1.5 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.\n\nNumber of participants entered into this arm consisted of:\n\nN=10 from DBP Placebo'}, {'id': 'FG004', 'title': 'BEP Cariprazine 3 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.\n\nNumber of participants entered into this arm consisted of:\n\nN=1 from DBP Placebo N=2 from DBP Cariprazine 3 mg N=1 from DBP Cariprazine 6 mg'}, {'id': 'FG005', 'title': 'BEP Cariprazine 6 mg', 'description': 'Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal daily dose during the 18-week BEP.\n\nNumber of participants entered into this arm consisted of:\n\nN=2 from DBP Cariprazine 3 mg N=8 from DBP Cariprazine 6 mg'}, {'id': 'FG006', 'title': 'SF DBP Placebo', 'description': 'Safety Follow up (SF) for DBP Placebo participants.'}, {'id': 'FG007', 'title': 'SF DBP Cariprazine 3 mg', 'description': 'SF for DBP Cariprazine 3 mg participants.'}, {'id': 'FG008', 'title': 'SF DBP Cariprazine 6 mg', 'description': 'SF for DBP Cariprazine 6 mg participants.'}, {'id': 'FG009', 'title': 'SF BEP Cariprazine 1.5 mg', 'description': 'SF for BEP Cariprazine 1.5 mg participants.'}, {'id': 'FG010', 'title': 'SF BEP Cariprazine 3 mg', 'description': 'SF for BEP Cariprazine 3 mg participants.'}, {'id': 'FG011', 'title': 'SF BEP Cariprazine 6 mg', 'description': 'SF for BEP Cariprazine 6 mg participants.'}], 'periods': [{'title': 'Double Blind Period (DBP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Blinded Extension Period (BEP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-up DBP (SF DBP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-up BEP (SF BEP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DBP Placebo', 'description': 'Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).'}, {'id': 'BG001', 'title': 'DBP Cariprazine 3 mg', 'description': 'Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'BG002', 'title': 'DBP Cariprazine 6 mg', 'description': 'Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '11.76', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '13.70', 'groupId': 'BG001'}, {'value': '43.7', 'spread': '10.88', 'groupId': 'BG002'}, {'value': '42.5', 'spread': '11.40', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'SCI-PANSS Total Score at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'spread': '8.70', 'groupId': 'BG000'}, {'value': '99.8', 'spread': '8.17', 'groupId': 'BG001'}, {'value': '91.8', 'spread': '7.37', 'groupId': 'BG002'}, {'value': '94.3', 'spread': '8.33', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). The SCI-PANSS total score can range from 30 to 210. Higher values represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Population included all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-25', 'size': 1887282, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-29T12:04', 'hasProtocol': True}, {'date': '2024-08-01', 'size': 1068971, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-29T12:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2022-05-06', 'resultsFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-07', 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.'}, {'measure': 'Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change in CGI-S Score From Baseline (Wk 0) to Week 6', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': "Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement."}, {'measure': 'Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}, {'measure': 'Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.'}, {'measure': 'Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}, {'measure': 'Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6', 'timeFrame': 'Baseline (Wk 0) to Week 6', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}, {'measure': 'Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}, {'measure': 'Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': "Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement."}, {'measure': 'Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}, {'measure': 'Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.'}, {'measure': 'Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}, {'measure': 'Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24', 'timeFrame': 'Baseline (Wk 0) and Week 6 to Week 24', 'description': 'Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Cariprazine', 'VRAYLAR'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M22-509', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed.\n\nCariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. In the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. Approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across Taiwan and Japan.\n\nParticipants will receive oral capsules of Cariprazine or placebo for the 6-week Double-blind Period (DBP). Upon completion of 6-week DBP, participants will be eligible to receive oral capsules of Cariprazine for additional 18 weeks in the Blinded Extension Period (BEP), followed by an 8-week safety follow-up period.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.', 'detailedDescription': 'Per the final protocol amendment 3, the number of dosing arms in the 6-week DBP of the study changed from 3 to 2. Participants enrolled in the study through Protocol Amendment 2 and who were randomized to the arm that was eliminated, remained in that arm through DBP and their data are displayed by that arm for the DBP portion of the study in participant flow, baseline characteristics and safety sections. Data for all endpoints are presented as planned per final SAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with schizophrenia at least 1 year before informed consent.\n* Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator.\n\nExclusion Criteria:\n\n\\- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug."}, 'identificationModule': {'nctId': 'NCT05368558', 'acronym': '509 JPN Schz', 'briefTitle': 'Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period', 'orgStudyIdInfo': {'id': 'M22-509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cariprazine', 'description': 'Participants will receive cariprazine Dose A daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.', 'interventionNames': ['Drug: Cariprazine', 'Drug: Placebo']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'otherNames': ['VRAYLAR'], 'description': 'Oral Capsule', 'armGroupLabels': ['Cariprazine', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010-8543', 'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'facility': 'Akita University Hospital /ID# 245941', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '2868520', 'city': 'Narita-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'International University of Health and Welfare Narita Hospital /ID# 243870'}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital /ID# 244404', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '819-0037', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kuramitsu Hospital /ID# 242511', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '836-0004', 'city': 'Omuta-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Shiranui Hospital /ID# 243717'}, {'zip': '501-1194', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu University Hospital /ID# 246238', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '509-5142', 'city': 'Toki-shi', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Holy Cross Hospital /ID# 242673'}, {'zip': '737-0111', 'city': 'Kure', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hayakawa Clinic /ID# 242432', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'zip': '737-0023', 'city': 'Kure-shi', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'National Hospital Organization Kure Medical Center /ID# 243405'}, {'zip': '002-8029', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Goryokai Hospital /ID# 242420', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-8543', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital /ID# 245135', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Duplicate_Hokkaido University Hospital /ID# 243245', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '761-0793', 'city': 'Kita-gun', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kagawa University Hospital /ID# 243772'}, {'zip': '891-0111', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Taniyama Hospital /ID# 242385', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '236-0004', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Hospital /ID# 244944', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '861-8002', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Yuge Hospital /ID# 242849', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '625-8502', 'city': 'Maizuru', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Maizuru Medical Center /ID# 243450', 'geoPoint': {'lat': 35.45, 'lon': 135.33333}}, {'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Mie University Hospital /ID# 244710', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '386-0401', 'city': 'Ueda-shi', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Mental Support Soyokaze Hospital /ID# 242512'}, {'zip': '634-8522', 'city': 'Kashihara-shi', 'state': 'Nara', 'country': 'Japan', 'facility': 'Nara Medical University Hospital /ID# 242561', 'geoPoint': {'lat': 34.50896, 'lon': 135.7929}}, {'zip': '590-0018', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Asakayama General Hospital /ID# 242732', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '842-0192', 'city': 'Kanzaki-gun', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Hizen Psychiatric Center /ID# 243239'}, {'zip': '847-0031', 'city': 'Karatsu-shi', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Rainbow & Sea Hospital /ID# 242699'}, {'zip': '841-0081', 'city': 'Tosu-shi', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Inuo Hospital /ID# 243310'}, {'zip': '343-0032', 'city': 'Koshigaya-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Juntendo Univ Koshigaya Hospital /ID# 248502'}, {'zip': '4108575', 'city': 'Numazu-shi', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Numazu Chuo Hospital /ID# 245275'}, {'zip': '329-1104', 'city': 'Utsunomiya', 'state': 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