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Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lurasidone |
|
| 2 | Active Comparator | Risperidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone HCl | Drug | 40 - 120mg per day |
| |
| Risperidone |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events. | 12 months |
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Main Inclusion Criteria:
To be eligible to enter the study, each patient must comply with the following inclusion criteria:
Main Exclusion Criteria:
To be excluded from entering this study if they fulfil any of the criteria below:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K&S Professional Research Services LLC | Little Rock | Arkansas | 72201 | United States | ||
| Woodland International Research Group, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21075600 | Background | Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31. | |
| 22395527 | Result | Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/YIC.0b013e32835281ef. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone | Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day |
| FG001 | Risperidone | Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Risperidone |
|
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| South Coast Clinical Trials, Inc. | Anaheim | California | 92804 | United States |
| Comprehensive NeuroScience, Inc. - Cerritos | Cerritos | California | 90703 | United States |
| Clinical Innovations Inc. | Costa Mesa | California | 92626 | United States |
| Collaborative Neuroscience Network Inc | Garden Grove | California | 92845 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| University of California at Irvine Medical Center | Orange | California | 92868 | United States |
| Pasadena Research Institute | Pasadena | California | 91107 | United States |
| CNRI-Los Angeles, LLC | Pico Rivera | California | 90660 | United States |
| Clinical Innovations Inc. | Riverside | California | 92506 | United States |
| CNRI-San Diego LLC | San Diego | California | 92102 | United States |
| UCSD, Outpatient Psychiatric Services | San Diego | California | 92103 | United States |
| Clinical Innovations Inc. | Santa Ana | California | 92705 | United States |
| Collaborative Neuroscience Network Inc | Torrance | California | 90502 | United States |
| Comprehensive NeuroScience, Inc. | Washington D.C. | District of Columbia | 20016 | United States |
| Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Fidelity Clinical Research Inc. | North Miami | Florida | 33161 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Northlake Medical Research Center | Tucker | Georgia | 30084 | United States |
| Alexian Brothers Medical Center | Hoffman Estates | Illinois | 60169 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70601 | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | 21285 | United States |
| Precise Research Center | Flowood | Mississippi | 39232 | United States |
| St. Charles Psychiatric Associates - Midwest Research | Saint Charles | Missouri | 63301 | United States |
| St. Louis Clinical Trials | St Louis | Missouri | 63118 | United States |
| Creighton University | Omaha | Nebraska | 68131 | United States |
| CRI Worldwide | Willingboro | New Jersey | 08046 | United States |
| SUNY Downstate University | Brooklyn | New York | 11203 | United States |
| Neurobehavioral Research Inc. | Cedarhurst | New York | 11516 | United States |
| Manhattan Psychiatric Center | New York | New York | 10035 | United States |
| Social Psychiatry Research Institute | New York | New York | 10454 | United States |
| University of North Carolina at Chapel Hill | Raleigh | North Carolina | 27603 | United States |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | United States |
| CRI Worldwide | Philadelphia | Pennsylvania | 19139 | United States |
| Research Strategies of Memphis LLC | Memphis | Tennessee | 38119 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| Pillar Clinical Research LLC | Dallas | Texas | 75243 | United States |
| Claghorn-Lesem Research Clinic, Inc. | Houston | Texas | 77008 | United States |
| Alliance Research Group | Richmond | Virginia | 23230 | United States |
| Fundación para el Estudio y Tratamiento de las Enf. Mentales | Capital Federal | BUE | C1425AHP | Argentina |
| Clinica Privada Neuropsiquiatrica San Agustin | La Plata | BUE | 1900 | Argentina |
| Resolution Psychopharmacology Research Institute | Mendoza | MEN | M5502HLE | Argentina |
| CIAP | Rosario | SFE | S2000QJI | Argentina |
| Sanatorio 'Prof. Leon S. Morra' S.A. | Córdoba | X5009BIN | Argentina |
| Sanatorio Sao Paulo | Salvador | Estado de Bahia | 40301-500 | Brazil |
| Hospital Espirita de Psiquiatria Bom Retiro | Curitiba | Paraná | 80520-000 | Brazil |
| Hospital Mario Kroeff | Rio de Janeiro | Rio de Janeiro | 21020-130 | Brazil |
| PAX Clinica Psiquiatrica Ltda | Aparecida de Goiânia | 74922-810 | Brazil |
| Hospital Clincio Felix Bulnes | Quinta Normal | Santiago Metropolitan | Chile |
| Instituto Psiquiátrico Dr. José Horwitz Barak | Recoleta | Santiago Metropolitan | Chile |
| Hospital Barros Luco Trudeau | San Miguel | Santiago Metropolitan | Chile |
| CIPAM - ClÃnica Pedro Montt | Santiago | Santiago Metropolitan | Chile |
| Hospital Base Valdivia | Valdivia | Valdivia | Chile |
| Psychiatric Hospital Vrapce | Zagreb | City of Zagreb | 10 090 | Croatia |
| Croatian institute for brain research Neuron | Zagreb | City of Zagreb | 10000 | Croatia |
| Clinical Hospital Centre Rijeka | Rijeka | Rijeka | 51 000 | Croatia |
| Beer Ya'acov Mental Health Center | Beer Yaakov | Beer Yaakov | 70300 | Israel |
| Rambam Health Care Campus | Haifa | Haifa District | 31096 | Israel |
| Shalvata Mental Health Center | Hod HaSharon | Hod Hasharon | 45100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | Ramat Gan | 52621 | Israel |
| Shalvata Mental Health Center, Ward B | Hod HaSharon | 45100 | Israel |
| Oranje Hospital | Bloemfontein | Free State | 9301 | South Africa |
| Rand Clinic | Johannesburg | Gauteng | 2198 | South Africa |
| Private Practice | Pretoria | Gauteng | 0181 | South Africa |
| Flexivest fourteen Research Centre | Cape Town | W Cape | 7535 | South Africa |
| Cape Trial Centre | Cape Town | 7530 | South Africa |
| Crompton Medical Centre East | Natal | 3600 | South Africa |
| Weskoppies Hospital | Pretoria West | 0001 | South Africa |
| King Chulalongkorn Memorial Hospital | Chulalongkorn University | Bangkok | Thailand |
| Somdet Chaopraya Institute of Psychiatry | Klongsan | Bangkok | Thailand |
| Suan Prung Psychiatric Hospital | Muang | Chiang Mai | Thailand |
| 33098548 | Derived | Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24. |
| 32370778 | Derived | Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1. |
| 28433500 | Derived | Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20. |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone | Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day |
| BG001 | Risperidone | Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | There were 9 subjects randomized to lurasidone but did not take study drug and thus there is a discrepancy of 9 subjects in the lurasidone treatment group between the participant population and the overall number of baseline participants. | Number | participants |
| |||||||||||||||
| Region of Enrollment | There were 9 subjects randomized to lurasidone but did not take study drug and thus there is a discrepancy of 9 subjects in the lurasidone treatment group between the participant population and the overall number of baseline participants. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events. | Posted | Sep 2011 | Number | participants | 12 months |
|
|
|
14 days post-study therapy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lurasidone | Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day | 46 | 419 | 349 | 419 | ||
| EG001 | Risperidone | Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed | 20 | 202 | 169 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Heart Disease | Cardiac disorders |
| |||
| Sinus Tachycardia | Cardiac disorders |
| |||
| Oculogyric Crisis | Eye disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Salivary Hypersecretion | Gastrointestinal disorders |
| |||
| Small Intestinal Obstruction | Gastrointestinal disorders |
| |||
| Sudden Death | General disorders |
| |||
| Appendicitis | Infections and infestations |
| |||
| Diverticulitis | Infections and infestations |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Clavicle Fracture | Injury, poisoning and procedural complications |
| |||
| Facial Bones Fracture | Injury, poisoning and procedural complications |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Femur Fracture | Injury, poisoning and procedural complications |
| |||
| Forearm Fracture | Injury, poisoning and procedural complications |
| |||
| Head Injury | Injury, poisoning and procedural complications |
| |||
| Rib Fracture | Injury, poisoning and procedural complications |
| |||
| Wrist Fracture | Injury, poisoning and procedural complications |
| |||
| Muscle Tightness | Musculoskeletal and connective tissue disorders |
| |||
| Muscular Weakness | Musculoskeletal and connective tissue disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Akathisia | Nervous system disorders |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Dystonia | Nervous system disorders |
| |||
| Loss of Consciousness | Nervous system disorders |
| |||
| Parkinsonism | Nervous system disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Tremor | Nervous system disorders |
| |||
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions |
| |||
| Antepartum Hemorrhage | Pregnancy, puerperium and perinatal conditions |
| |||
| Agitation | Psychiatric disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Conduct Disorder | Psychiatric disorders |
| |||
| Delusion of Reference | Psychiatric disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Paranoia | Psychiatric disorders |
| |||
| Psychotic Disorder | Psychiatric disorders |
| |||
| Schizoaffective Disorder | Psychiatric disorders |
| |||
| Schizophrenia | Psychiatric disorders |
| |||
| Suicidal Ideation | Psychiatric disorders |
| |||
| Suicide Attempt | Psychiatric disorders |
| |||
| Dsypnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Angioedema | Skin and subcutaneous tissue disorders |
| |||
| Rash Maculo-papular | Skin and subcutaneous tissue disorders |
| |||
| Rash Pruritic | Skin and subcutaneous tissue disorders |
| |||
| Physical Assault | Social circumstances |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Weight Decreased | Investigations |
| |||
| Weight Increased | Investigations |
| |||
| Akathisia | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dystonia | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Parkinsonism | Nervous system disorders |
| |||
| Sedation | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josephine Cucchiaro, PhD; Executive Director | Sunovion | 201-592-2050 | josephine.cucchiaro@sunovion.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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| Male |
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| Argentina |
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| Brazil |
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| Thailand |
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| Croatia |
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| Israel |
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| Chile |
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| South Africa |
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