Viewing Study NCT00868959


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Ignite Modification Date: 2026-02-26 @ 2:08 PM
Study NCT ID: NCT00868959
Status: COMPLETED
Last Update Posted: 2016-04-14
First Post: 2009-03-23
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069056', 'term': 'Lurasidone Hydrochloride'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-866-503-6351', 'title': 'Medical Director, CNS', 'organization': 'Sunovion'}, 'certainAgreement': {'otherDetails': 'In addition to the \\<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 Weeks', 'description': 'January 22, 2009 - February 19, 2013 - recruitment period', 'eventGroups': [{'id': 'EG000', 'title': 'Lurasidone', 'description': 'lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks', 'otherNumAtRisk': 813, 'otherNumAffected': 246, 'seriousNumAtRisk': 813, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 90, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 84, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 76, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 54, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 56, 'numAffected': 47}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 60, 'numAffected': 52}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hand Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Humerous Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lip Neoplasm Malignant Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression Suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 813, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '813', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '529', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '813', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '10.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The MADRS is a clinician-rated assessment of the subject\'s level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '813', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '1.325', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lurasidone', 'description': 'lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '817 represents total number of subjects who provided informed consent.', 'groupId': 'FG000', 'numSubjects': '817'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '559'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}]}]}], 'preAssignmentDetails': '817 represents the total number of subjects who provided informed consent and enrolled, which is different from the total number of subjects who were treated with study drug, which was 813.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '813', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lurasidone', 'description': 'lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '12.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '790', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '427', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '386', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population - received at least one dose of study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 817}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2009-03-23', 'resultsFirstSubmitDate': '2014-02-17', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-17', 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment', 'timeFrame': '24 weeks', 'description': 'Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)'}], 'secondaryOutcomes': [{'measure': 'Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': '24 weeks', 'description': 'The MADRS is a clinician-rated assessment of the subject\'s level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.'}, {'measure': 'Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)', 'timeFrame': '24 weeks', 'description': 'This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bipolar', 'Depression', 'Lurasidone', 'Latuda'], 'conditions': ['Bipolar Depression']}, 'referencesModule': {'references': [{'pmid': '29146409', 'type': 'DERIVED', 'citation': 'Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment\n* Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.\n\nExclusion Criteria:\n\n* Imminent risk of suicide, injury to self or to others, or damage to property\n* Subject has evidence of severe movement disorders.\n* Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).'}, 'identificationModule': {'nctId': 'NCT00868959', 'briefTitle': 'Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression', 'orgStudyIdInfo': {'id': 'D1050256'}, 'secondaryIdInfos': [{'id': 'EUDRACT No. 2008-007483-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lurasidone', 'interventionNames': ['Drug: lurasidone']}], 'interventions': [{'name': 'lurasidone', 'type': 'DRUG', 'description': 'Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks', 'armGroupLabels': ['lurasidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Inc', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'South Coast Clinical Trials Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Escondido', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92645', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network Inc', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32751', 'city': 'Maitland', 'state': 'California', 'country': 'United States', 'facility': 'Florida Clinical Research Center LLC'}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research, Inc', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90660', 'city': 'Pico Rivera', 'state': 'California', 'country': 'United States', 'facility': 'CNRI - Los Angeles LLC', 'geoPoint': {'lat': 33.98307, 'lon': -118.09673}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations Inc.', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Neuropsychopharmacology Clinical Research Instit', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mesa Vista Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations Inc.', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network Inc.', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80917', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'MCB Clinical Research Centers-Colorado Springs', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34731', 'city': 'Fruitland Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center LLC', 'geoPoint': {'lat': 28.86138, 'lon': -81.90647}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Accurate Clinical Trials', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions INc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Institute - 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