Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-01-01 @ 5:07 PM
Study NCT ID:
NCT01104792
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Study of Cariprazine in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania', 'South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@allergan.com,', 'phone': '714-246-4500', 'title': 'Willie R. Earley, MD Associate Vice President Clinical Development-CNS', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': "The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability.\n\nSafety population: All enrolled participants who took at least 1 dose of cariprazine.", 'eventGroups': [{'id': 'EG000', 'title': 'Cariprazine', 'description': 'Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.', 'otherNumAtRisk': 586, 'deathsNumAtRisk': 586, 'otherNumAffected': 419, 'seriousNumAtRisk': 586, 'deathsNumAffected': 0, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 79}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 118}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 104}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 104}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 68}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 49}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Autoimmune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Medical device pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Psychotic behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 6}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 48 in the PANSS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine', 'description': 'Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '66.5', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '14.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline efficacy assessment. Only participants with data at both Baseline and Week 48 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in the CGI-S Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cariprazine', 'description': 'Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': "The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cariprazine', 'description': 'Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '752'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '179'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Reasons Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Did Not Meet Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '133'}]}]}], 'preAssignmentDetails': "The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cariprazine', 'description': 'Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '178', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '408', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '523', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '250', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.94', 'spread': '20.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.10', 'spread': '5.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '91.76', 'spread': '15.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Summary statistics for this parameter based on 586 patients.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability."}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 752}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2014-03-28', 'completionDateStruct': {'date': '2013-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2010-04-12', 'dispFirstSubmitQcDate': '2014-03-28', 'resultsFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2010-04-14', 'dispFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-25', 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 48 in the PANSS Total Score', 'timeFrame': 'Baseline to Week 48', 'description': 'The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 48 in the CGI-S Score', 'timeFrame': 'Baseline to Week 48', 'description': "The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Acute schizophrenia', 'Psychotropic drugs', 'Antipsychotic agents', 'Mental disorders', 'Dopamine agents', 'Central nervous system agents'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '34091867', 'type': 'DERIVED', 'citation': 'Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.'}, {'pmid': '33854317', 'type': 'DERIVED', 'citation': 'Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.'}, {'pmid': '28836957', 'type': 'DERIVED', 'citation': 'Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures.\n* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).\n* Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).\n\nExclusion Criteria:\n\n* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.'}, 'identificationModule': {'nctId': 'NCT01104792', 'briefTitle': 'Long-term Study of Cariprazine in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'RGH-MD-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cariprazine', 'description': 'Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.', 'interventionNames': ['Drug: Cariprazine']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'otherNames': ['RGH-188'], 'description': 'Cariprazine was supplied in capsules.', 'armGroupLabels': ['Cariprazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72201', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 072', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 021', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 086', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 014', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '90746', 'city': 'Carson', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 080', 'geoPoint': {'lat': 33.83141, 'lon': -118.28202}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 079', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 048', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 070', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 022', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 083', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 050', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 006', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 003', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 016', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 073', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Forest Investigative Site 071', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 002', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 041', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 082', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 055', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 087', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Forest Investigative Site 012', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 008', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 044', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Forest Investigative Site 007', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 017', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 076', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '63118', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 045', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Forest Investigative Site 052', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Forest Investigative Site 004', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 040', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '44094', 'city': 'Willoughby', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 019', 'geoPoint': {'lat': 41.63977, 'lon': -81.4065}}, {'zip': '19131', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 077', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 047', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 074', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 084', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '75062', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 043', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site 078', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '051053', 'city': 'Bello', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Forest Investigative Site 601', 'geoPoint': {'lat': 6.33732, 'lon': -75.55795}}, {'zip': '660003', 'city': 'Pereira', 'state': 'Risaralda Department', 'country': 'Colombia', 'facility': 'Forest Investigative Site 604', 'geoPoint': {'lat': 4.81428, 'lon': -75.69488}}, {'zip': '110121', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Forest Investigative Site 602', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '111166', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Forest Investigative Site 605', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '380006', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Forest Investigative Site 503', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380006', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Forest Investigative Site 519', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380013', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Forest Investigative Site 501', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '431005', 'city': 'Aurangabad', 'country': 'India', 'facility': 'Forest Investigative Site 500', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'zip': '208005', 'city': 'Kanpur', 'country': 'India', 'facility': 'Forest Investigative Site 507', 'geoPoint': {'lat': 26.46523, 'lon': 80.34975}}, {'zip': '226006', 'city': 'Lucknow', 'country': 'India', 'facility': 'Forest Investigative Site 518', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '575001', 'city': 'Mangalore', 'country': 'India', 'facility': 'Forest Investigative Site 517', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '575018', 'city': 'Mangalore', 'country': 'India', 'facility': 'Forest Investigative Site 515', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '400026', 'city': 'Mumbai', 'country': 'India', 'facility': 'Forest Investigative Site 510', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '422101', 'city': 'Nashik', 'country': 'India', 'facility': 'Forest Investigative Site 513', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '360002', 'city': 'Rajkot', 'country': 'India', 'facility': 'Forest Investigative Site 509', 'geoPoint': {'lat': 22.29161, 'lon': 70.79322}}, {'zip': '201010', 'city': 'Varanasi', 'country': 'India', 'facility': 'Forest Investigative Site 506', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '520002', 'city': 'Vijaywada', 'country': 'India', 'facility': 'Forest Investigative Site 505'}, {'zip': '41914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 306', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400012', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Forest Investigative Site 301', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '200620', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Forest Investigative Site 300', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '200745', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Forest Investigative Site 311', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '130086', 'city': 'Târgovişte', 'country': 'Romania', 'facility': 'Forest Investigative Site 303', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'zip': '540142', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Forest Investigative Site 304', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '163530', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Forest Investigative Site 102', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '454087', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Forest Investigative Site 103', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '672090', 'city': 'Chita', 'country': 'Russia', 'facility': 'Forest Investigative Site 104', 'geoPoint': {'lat': 52.04311, 'lon': 113.49171}}, {'zip': '190121', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 112', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192019', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 105', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192019', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 106', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192019', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 113', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '193167', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 107', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 109', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Forest Investigative Site 110', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '410060', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Forest Investigative Site 108', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '634014', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Forest Investigative Site 100', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '08631', 'city': 'Hlevakha', 'state': 'Kyiv Oblast', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 211', 'geoPoint': {'lat': 50.27423, 'lon': 30.32706}}, {'zip': '73488', 'city': 'Kherson', 'state': 'Stepanivka', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 206', 'geoPoint': {'lat': 46.63695, 'lon': 32.61458}}, {'zip': '49005', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 208', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '49027', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 205', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83008', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 200', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 203', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 204', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '04080', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 201', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79021', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 202', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '36006', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 209', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '95006', 'city': 'Simferopol', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 210', 'geoPoint': {'lat': 44.95719, 'lon': 34.11079}}, {'zip': '21005', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 207', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'overallOfficials': [{'name': 'Raffaele Migliore, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gedeon Richter Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}