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Pediatric Open-Label Extension Study

NCT ID: NCT01914393

Last Updated: 2019-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-10-17

Brief Summary

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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

Detailed Description

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Conditions

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Schizophrenia Autism Bipolar Depression

Keywords

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Schizophrenia Autism Lurasidone Latuda

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily

Group Type EXPERIMENTAL

Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Intervention Type DRUG

Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed

Interventions

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Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed

Intervention Type DRUG

Other Intervention Names

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Latuda

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lurasidone Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

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Harmonex Neuroscience Research

Dothan, Alabama, United States

Site Status

Diligent Clinical Trials, Inc

Downey, California, United States

Site Status

University of California San Francisco Medical Center

San Francisco, California, United States

Site Status

Neuropsychiatric Research Center of Orange County

Santa Ana, California, United States

Site Status

Sarkis Clinical Trials - Parent

Gainesville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

APG Research, LLC

Orlando, Florida, United States

Site Status

Medical Research Group of Central Florida

Sanford, Florida, United States

Site Status

University of South Florida

St. Petersburg, Florida, United States

Site Status

University of South Florida Rothman Center of Neuropychiatry

Tampa, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Attalla Consultants, LLC

Smyrna, Georgia, United States

Site Status

Psychiatric Associates

Overland Park, Kansas, United States

Site Status

University Of Kentucky

Lexington, Kentucky, United States

Site Status

Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

Lake Charles, Louisiana, United States

Site Status

Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status

Neurobehavioral medicine Group, LLC

Bloomfield Hills, Michigan, United States

Site Status

St. Charles Psychiatric Associates

Saint Charles, Missouri, United States

Site Status

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

North Shore/Long Island Jewish PRIME

Glen Oaks, New York, United States

Site Status

Dr. Jeanette Cueva

Mount Kisco, New York, United States

Site Status

Montefiore Medical Center PRIME

New York, New York, United States

Site Status

Finger Lakes Clinical Research

Rochester, New York, United States

Site Status

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

The Ohio State University Nisonger Center

Columbus, Ohio, United States

Site Status

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Site Status

Pillar Clinical Research, LLC

Dallas, Texas, United States

Site Status

Family Psychiatry of The Woodlands, P.A.

The Woodlands, Texas, United States

Site Status

Ericksen Research & Development, LLC

Clinton, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Neuroscience, Inc.

Herndon, Virginia, United States

Site Status

Clinical Research Partners, LLC

Petersburg, Virginia, United States

Site Status

Carilion Clinic

Roanoke, Virginia, United States

Site Status

MHC - Ruse, EOOD

Rousse, , Bulgaria

Site Status

UMHAT "Alexandrovska" EAD

Sofia, , Bulgaria

Site Status

MHAT-Targovishte, AD

Targovishte, , Bulgaria

Site Status

DCC "Mladost M" - Varna, OOD

Varna, , Bulgaria

Site Status

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, , Colombia

Site Status

E.S.E. Hospital Mental de Antioquia

Bello, , Colombia

Site Status

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

Bogotá, , Colombia

Site Status

CHU Nantes - Hôpital Mère-Enfant

Nantes, , France

Site Status

Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

Budapest, , Hungary

Site Status

Bekes Megyei Pandy Kalman Korhaz

Gyula, , Hungary

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

Culiacán, Sinaloa, Mexico

Site Status

Dr. Jessica Rosas Escobar

Durango, , Mexico

Site Status

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Site Status

Accelerium S. de R.L. de C.V.

Monterrey, , Mexico

Site Status

Instituto de Informacion de Investigacion en Salud Mental

Monterrey, , Mexico

Site Status

Av Modesto Arreola #917 Ote. Col Centro

Nuevo León, , Mexico

Site Status

Alexian Brothers Health and Wellness Center

Davao City, , Philippines

Site Status

West Visayas State University Medical Center

Iloilo City, , Philippines

Site Status

National Center for Mental Health

Mandaluyong, , Philippines

Site Status

Veterans Memorial Medical Center

Quezon City, , Philippines

Site Status

NZOZ Poradnia Zdrowia Psychicznego

Kobierzyce, , Poland

Site Status

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy

Torun, , Poland

Site Status

Centro de Investigacion Clinica Psiquiatrica

Caguas, , Puerto Rico

Site Status

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

Bucharest, , Romania

Site Status

Spitalul Clinic de Psihiatrie Socola

Iași, , Romania

Site Status

Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

Timișoara, , Romania

Site Status

GUZ Lipetsk Regional psychoneurological Hospital #1

Lipetsk, , Russia

Site Status

Closed corporation "Scientific Center of Personalized Psychiatry"

Moscow, , Russia

Site Status

Scientific Center of Personalized Psychiatry

Moscow, , Russia

Site Status

State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"

Nizhny Novgorod, , Russia

Site Status

SHI "City Psychoneurological dispensary #7 (with Hospital)"

Saint Petersburg, , Russia

Site Status

Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin

Saint Petersburg, , Russia

Site Status

Bekhterev Institute

Saint Petersburg, , Russia

Site Status

Regional Clinical Mental Hospital of Saint Sofiya

Saratov, , Russia

Site Status

FSBSI "Scientific Research Institute of Mental Health"

Tomsk, , Russia

Site Status

State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"

Yaroslavl, , Russia

Site Status

Sverdiovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, , Russia

Site Status

Seoul National University Hospital

Seoul, Gyeonggi-do, South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Hospital Marítimo de Torremolinos

Torremolinos, Málaga, Spain

Site Status

RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

Ivano-Frankivsk, , Ukraine

Site Status

SI Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, , Ukraine

Site Status

SI Institute of Children and Adolescents Healthcare of NAMSU

Kharkiv, , Ukraine

Site Status

TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

Kyiv, , Ukraine

Site Status

CI Lviv Regional Clinical Psychiatric Hospital

Lviv, , Ukraine

Site Status

Odesa Regional Psychoneurological Dispensary, Outpatient Dept.

Odesa, , Ukraine

Site Status

O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

Poltava, , Ukraine

Site Status

CI Kherson Regional Psychiatric Hospital of Kherson RC

Stepanovka, , Ukraine

Site Status

Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

Ternopil, , Ukraine

Site Status

Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

Vinnitsia, , Ukraine

Site Status

Countries

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United States Bulgaria Colombia France Hungary Malaysia Mexico Philippines Poland Puerto Rico Romania Russia South Korea Spain Ukraine

References

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DelBello MP, Tocco M, Pikalov A, Deng L, Goldman R. Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. J Child Adolesc Psychopharmacol. 2021 Sep;31(7):494-503. doi: 10.1089/cap.2021.0040. Epub 2021 Jul 29.

Reference Type DERIVED
PMID: 34324397 (View on PubMed)

Provided Documents

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Document Type: Study Protocol: Final Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2013-001694-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D1050302

Identifier Type: -

Identifier Source: org_study_id