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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000682-12 | EudraCT Number |
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This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental | Lurasidone flexibly dosed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Okanagan Clinical Trials | Kelowna | British Columbia | V1Y 1Z9 | Canada | ||
| Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone | Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Barranquilla |
| Colombia |
| E.S.E. Hospital Mental de Antioquia | Bello | Colombia |
| CISNE - UIC Campo Abierto | Bogotá | Colombia |
| Psychiatricka ambulance | Brno-mesto | 602 00 | Czechia |
| Vojenska nemocnice Olomouc | Olomouc | 711 11 | Czechia |
| Clintrial, s.r.o. | Prague | 10 100 00 | Czechia |
| Psychiatry Trial s.r.o. | Prague | 158 00 | Czechia |
| Medical Services Prague s.r.o. | Prague | 6 160 00 | Czechia |
| Zans Ritter, Marcel | Orvault | 44700 | France |
| Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS) | Toulun | 83000 | France |
| Brain Mind Behavior Neuroscience Research Institute | Visakhapatnam | Andh Prad | 530002 | India |
| Vijayawada Institute of Mental Health and Neurosciences | Vijayawada | Andhra Pradesh | 520002 | India |
| Samvedna Hospitals | Ahmedabad | Gujarat | 380006 | India |
| Seth K M School of P G Medicine & Research | Ahmedabad | Gujarat | 380006 | India |
| Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry | Ahmedabad | Gujarat | 380013 | India |
| Hatkesh Healthcare Foundation | Jūnāgadh | Gujarat | 362001 | India |
| Brij Psychiatry Hospital & Muskaan Research Centre | Vadodara | Gujarat | 390001 | India |
| Shanti Nursing Home | Aurangabad | Maharashtra | 431005 | India |
| Dr. Tambi's Neuropsychiatry Center | Jaipur | Rajaasthan | 302017 | India |
| R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry | Jaipur | Rajasthan | 302021 | India |
| Mahendru Psychiatric Centre | Kanpur | 208005 | India |
| Neuromeda JSC | Kaunas | 50185 | Lithuania |
| JSC Neuromeda | Kaunas | LT-50185 | Lithuania |
| Seskines Outpatient Clinic, Public Institution | Vilnius | 07156 | Lithuania |
| Spitalul Clinic Judetean de Urgenta Cluj | Cluj-Napoca | 400012 | Romania |
| Spitalul Clinic de Neuropsihiatrie Craiova | Craiova | 200620 | Romania |
| Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital' | Lipetsk | 398007 | Russia |
| St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1 | Saint Petersburg | 19005 | Russia |
| St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor) | Saint Petersburg | 191119 | Russia |
| St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6" | Saint Petersburg | 191167 | Russia |
| Institute of Mental Health | Belgrade | 11000 | Serbia |
| Clinical Centre Nis, Clinic for mental health protection | Niš | 18000 | Serbia |
| Psychiatricka ambulancia Mentum s.r.o. | Bratislava | 82007 | Slovakia |
| PsychoLine s.r.o. Psychiatricka ambulancia | Rimavská Sobota | 97901 | Slovakia |
| Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia | Svidník | 08901 | Slovakia |
| Pro mente sana s.r.o. Psychiaricka ambulancia | Trenčín | 91101 | Slovakia |
| Dey Clinic | Pretoria | Gauteng | 181 | South Africa |
| Cape Trial Centre | Tygervalley | Western Cape | 7530 | South Africa |
| Denmar Hospital Consulting Rooms | Pretoria | 0081 | South Africa |
| Kherson Regional Psychiatric Hospital | Kherson | Vil Stepanivka | 73488 | Ukraine |
| Dnipropetrovsk Regional Clinical Hospital named Mechnikov | Dnipropetrovsk | 49005 | Ukraine |
| Regional Clinical Psychiatric Hospital, Dept #11 | Donetsk | 83037 | Ukraine |
| Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine | Khardov | 61068 | Ukraine |
| Crimean republican Clinical Psychiatric Hospital | Simferopol | Ukraine |
| Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21 | Vinnitsia | 21018 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone | Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring. | Safety Population - subjects who took at least one dose of study medication | Posted | Number | participants | 18 months |
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| Secondary | Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | Only 153 subjects who had baseline and at least one post-baseline assessments. | Posted | Mean | Standard Deviation | units on a scale | 18 months |
|
|
18 Months
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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 flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food | 7 | 162 | 40 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pilonidal cyst | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Depression suicidal | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Hepatic enzyme increase | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed.
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 post completion of study at all sites, PI shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sunovion | 1-866-503-6351 | clinicaltrialdisclosure@sunvion.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| 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 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Czech Republic |
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| Slovakia |
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| Canada |
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| Ukraine |
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| Romania |
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| Lithuania |
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| Russian Federation |
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| South Africa |
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| Colombia |
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| India |
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| Title | Measurements |
|---|---|
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