--- title: Pediatric Open-Label Extension Study nct_id: NCT01914393 overall_status: COMPLETED phase: PHASE3 sponsor: Sumitomo Pharma America, Inc. study_type: INTERVENTIONAL primary_condition: Schizophrenia countries: United States, Bulgaria, Colombia, France, Hungary, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Ukraine canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01914393.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01914393" ct_last_update_post_date: 2019-12-19 last_seen_at: "2026-05-12T07:26:41.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Pediatric Open-Label Extension Study **Official Title:** A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects **NCT ID:** [NCT01914393](https://clinicaltrials.gov/study/NCT01914393) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 702 - **Lead Sponsor:** Sumitomo Pharma America, Inc. - **Conditions:** Schizophrenia, Autism, Bipolar Depression - **Start Date:** 2013-09-30 - **Completion Date:** 2018-10-17 - **CT.gov Last Update:** 2019-12-19 ## Brief Summary This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326 ## Eligibility - **Minimum age:** 6 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. * Subject has completed Study D1050301 (Visit 9) OR * Subject has completed Study D1050325 (Visit 9) OR * Subject has completed Study D1050326 (Visit 8) * Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol. * A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study * Females who participate in this study: * are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR- * practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR- * are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. * Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. Exclusion Criteria: * Subject is considered by the investigator to be at imminent risk of suicide. * Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator. ``` ## Arms - **Lurasidone 20, 40, 60, 80 mg, flexibly dosed** (EXPERIMENTAL) — Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily ## Interventions - **Lurasidone 20, 40, 60, 80 mg, flexibly dosed** (DRUG) — Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed ## Primary Outcomes - **Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)** _(time frame: During 104 Weeks (2-years) treatment period)_ — The Safety population consists of all subjects who received at least one dose of study drug in this study. ## Secondary Outcomes - **Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in PANSS Positive Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in PANSS Negative Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in PANSS General Psychopathology Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in PANSS Excitability Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in the Clinical Global Impression -Severity Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Clinical Global Impression (CGI) - Severity Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ - **Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score** _(time frame: Open-Label Baseline, Week 28, Week 52, and Week 104)_ ## Locations (88) - Harmonex Neuroscience Research, Dothan, Alabama, United States - Diligent Clinical Trials, Inc, Downey, California, United States - University of California San Francisco Medical Center, San Francisco, California, United States - Neuropsychiatric Research Center of Orange County, Santa Ana, California, United States - Sarkis Clinical Trials - Parent, Gainesville, Florida, United States - Clinical Neuroscience Solutions, Inc., Orlando, Florida, United States - APG Research, LLC, Orlando, Florida, United States - Medical Research Group of Central Florida, Sanford, Florida, United States - University of South Florida, St. Petersburg, Florida, United States - University of South Florida Rothman Center of Neuropychiatry, Tampa, Florida, United States - Atlanta Center for Medical Research, Atlanta, Georgia, United States - Attalla Consultants, LLC, Smyrna, Georgia, United States - Psychiatric Associates, Overland Park, Kansas, United States - University Of Kentucky, Lexington, Kentucky, United States - Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340, Lake Charles, Louisiana, United States - Kennedy Krieger Institute, Baltimore, Maryland, United States - Neurobehavioral medicine Group, LLC, Bloomfield Hills, Michigan, United States - St. Charles Psychiatric Associates, Saint Charles, Missouri, United States - Jersey Shore University Medical Center, Neptune City, New Jersey, United States - North Shore/Long Island Jewish PRIME, Glen Oaks, New York, United States - Dr. Jeanette Cueva, Mount Kisco, New York, United States - Montefiore Medical Center PRIME, New York, New York, United States - Finger Lakes Clinical Research, Rochester, New York, United States - Richmond Behavioral Associates, Staten Island, New York, United States - University of Cincinnati Medical Center, Cincinnati, Ohio, United States - University Hospitals Case Medical Center, Cleveland, Ohio, United States - The Ohio State University Nisonger Center, Columbus, Ohio, United States - Cutting Edge Research Group, Oklahoma City, Oklahoma, United States - Pillar Clinical Research, LLC, Dallas, Texas, United States - Family Psychiatry of The Woodlands, P.A., The Woodlands, Texas, United States - Ericksen Research & Development, LLC, Clinton, Utah, United States - University of Virginia, Charlottesville, Virginia, United States - Neuroscience, Inc., Herndon, Virginia, United States - Clinical Research Partners, LLC, Petersburg, Virginia, United States - Carilion Clinic, Roanoke, Virginia, United States - MHC - Ruse, EOOD, Rousse, Bulgaria - UMHAT "Alexandrovska" EAD, Sofia, Bulgaria - MHAT-Targovishte, AD, Targovishte, Bulgaria - DCC "Mladost M" - Varna, OOD, Varna, Bulgaria - Centro de Investigaciones y Proyectos en Neurociencias CIPNA, Barranquilla, Colombia - E.S.E. Hospital Mental de Antioquia, Bello, Colombia - Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda, Bogotá, Colombia - CHU Nantes - Hôpital Mère-Enfant, Nantes, France - Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert, Budapest, Hungary - Bekes Megyei Pandy Kalman Korhaz, Gyula, Hungary - University Malaya Medical Centre, Kuala Lumpur, Malaysia - Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C., Culiacán, Sinaloa, Mexico - Dr. Jessica Rosas Escobar, Durango, Mexico - Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango, Mexico - Accelerium S. de R.L. de C.V., Monterrey, Mexico - Instituto de Informacion de Investigacion en Salud Mental, Monterrey, Mexico - Av Modesto Arreola #917 Ote. Col Centro, Nuevo León, Mexico - Alexian Brothers Health and Wellness Center, Davao City, Philippines - West Visayas State University Medical Center, Iloilo City, Philippines - National Center for Mental Health, Mandaluyong, Philippines - Veterans Memorial Medical Center, Quezon City, Philippines - NZOZ Poradnia Zdrowia Psychicznego, Kobierzyce, Poland - Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy, Torun, Poland - Centro de Investigacion Clinica Psiquiatrica, Caguas, Puerto Rico - Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Bucharest, Romania - Spitalul Clinic de Psihiatrie Socola, Iași, Romania - Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara, Timișoara, Romania - GUZ Lipetsk Regional psychoneurological Hospital #1, Lipetsk, Russia - Closed corporation "Scientific Center of Personalized Psychiatry", Moscow, Russia - Scientific Center of Personalized Psychiatry, Moscow, Russia - State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod", Nizhny Novgorod, Russia - SHI "City Psychoneurological dispensary #7 (with Hospital)", Saint Petersburg, Russia - Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin, Saint Petersburg, Russia - Bekhterev Institute, Saint Petersburg, Russia - Regional Clinical Mental Hospital of Saint Sofiya, Saratov, Russia - FSBSI "Scientific Research Institute of Mental Health", Tomsk, Russia - State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital", Yaroslavl, Russia - Sverdiovsk Regional Clinical Psychiatric Hospital, Yekaterinburg, Russia - Seoul National University Hospital, Seoul, Gyeonggi-do, South Korea - Chonnam National University Hospital, Gwangju, South Korea - Inha University Hospital, Incheon, South Korea - Chonbuk National University Hospital, Jeonju, South Korea - Hospital Marítimo de Torremolinos, Torremolinos, Málaga, Spain - RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU, Ivano-Frankivsk, Ukraine - SI Institute of Neurology, Psychiatry and Narcology of NAMSU, Kharkiv, Ukraine - SI Institute of Children and Adolescents Healthcare of NAMSU, Kharkiv, Ukraine - TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions, Kyiv, Ukraine - CI Lviv Regional Clinical Psychiatric Hospital, Lviv, Ukraine - Odesa Regional Psychoneurological Dispensary, Outpatient Dept., Odesa, Ukraine - O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy, Poltava, Ukraine - CI Kherson Regional Psychiatric Hospital of Kherson RC, Stepanovka, Ukraine - Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU, Ternopil, Ukraine - Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI, Vinnitsia, Ukraine ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.harmonex neuroscience research|dothan|alabama|united states` — added _(2026-05-12)_ - `locations.diligent clinical trials, inc|downey|california|united states` — added _(2026-05-12)_ - `locations.av modesto arreola #917 ote. col centro|nuevo león||mexico` — added _(2026-05-12)_ - `locations.university of california san francisco medical center|san francisco|california|united states` — added _(2026-05-12)_ - `locations.neuropsychiatric research center of orange county|santa ana|california|united states` — added _(2026-05-12)_ - `locations.sarkis clinical trials - parent|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.clinical neuroscience solutions, inc.|orlando|florida|united states` — added _(2026-05-12)_ - `locations.apg research, llc|orlando|florida|united states` — added _(2026-05-12)_ - `locations.medical research group of central florida|sanford|florida|united states` — added _(2026-05-12)_ - `locations.university of south florida|st. petersburg|florida|united states` — added _(2026-05-12)_ - `locations.university of south florida rothman center of neuropychiatry|tampa|florida|united states` — added _(2026-05-12)_ - `locations.atlanta center for medical research|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.attalla consultants, llc|smyrna|georgia|united states` — added _(2026-05-12)_ - `locations.psychiatric associates|overland park|kansas|united states` — added _(2026-05-12)_ - `locations.university of kentucky|lexington|kentucky|united states` — added _(2026-05-12)_ - `locations.lake charles clinical trials llc,2770 3rd avenue,suite 340|lake charles|louisiana|united states` — added _(2026-05-12)_ - `locations.kennedy krieger institute|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.neurobehavioral medicine group, llc|bloomfield hills|michigan|united states` — added _(2026-05-12)_ - `locations.st. charles psychiatric associates|saint charles|missouri|united states` — added _(2026-05-12)_ - `locations.jersey shore university medical center|neptune city|new jersey|united states` — added _(2026-05-12)_ - `locations.north shore/long island jewish prime|glen oaks|new york|united states` — added _(2026-05-12)_ - `locations.dr. jeanette cueva|mount kisco|new york|united states` — added _(2026-05-12)_ - `locations.montefiore medical center prime|new york|new york|united states` — added _(2026-05-12)_ - `locations.finger lakes clinical research|rochester|new york|united states` — added _(2026-05-12)_ - `locations.richmond behavioral associates|staten island|new york|united states` — added _(2026-05-12)_ - `locations.university of cincinnati medical center|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.university hospitals case medical center|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.the ohio state university nisonger center|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.cutting edge research group|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.pillar clinical research, llc|dallas|texas|united states` — added _(2026-05-12)_ - `locations.family psychiatry of the woodlands, p.a.|the woodlands|texas|united states` — added _(2026-05-12)_ - `locations.ericksen research & development, llc|clinton|utah|united states` — added _(2026-05-12)_ - `locations.university of virginia|charlottesville|virginia|united states` — added _(2026-05-12)_ - `locations.neuroscience, inc.|herndon|virginia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01914393.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01914393* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*