Phase
Condition
Autism
Bipolar Disorder
Tourette's Syndrome
Treatment
N/AClinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent from parent(s) or legal guardian(s) with sufficientintellectual capacity to understand the study and support subjects' participation inthe study procedures must be obtained for subjects who are not emancipated. Inaccordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC)requirements, the subject will complete an informed assent when developmentallyappropriate, to participate in the study before conduct of any study-specificprocedures.
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 lurasidonetreatment, and is able to comply with the protocol.
A reliable informant (eg, parent, legal guardian, or caregiver) must be available toaccompany the subject at each visit. For subjects entering from Study D1050325, thereliable caregiver must also oversee the administration of the study drug throughoutthe 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 remainabstinent from signing informed consent to at least 7 days after the last dose ofstudy drug has been taken; -OR-
are sexually active and willing to use a medically effective method of birthcontrol (eg, male using condom and female using condom, diaphragm, contraceptivesponge, spermicide, contraceptive pill, or intrauterine device) from signinginformed consent to at least 7 days after the last dose of study drug has beentaken.
Males must be willing to remain sexually abstinent (consistent with lifestyle) or usean effective method of birth control (eg, male using condom and female using condom,diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterinedevice) from signing informed consent to at least 7 days after the last dose of studydrug has been taken.
Exclusion
Exclusion Criteria:
Subject is considered by the investigator to be at imminent risk of suicide.
Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardivedyskinesia, or any other moderate or severe movement disorder. Severity to bedetermined by the investigator.
Study Design
Connect with a study center
MHC - Ruse, EOOD
Ruse, 7003
BulgariaSite Not Available
UMHAT "Alexandrovska" EAD
Sofia, 1431
BulgariaSite Not Available
MHAT-Targovishte, AD
Targovishte, 7700
BulgariaSite Not Available
DCC "Mladost M" - Varna, OOD
Varna, 9020
BulgariaSite Not Available
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla,
ColombiaSite Not Available
E.S.E. Hospital Mental de Antioquia
Bello, 0000
ColombiaSite Not Available
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogota, 00000
ColombiaSite Not Available
CHU Nantes - Hôpital Mère-Enfant
Nantes Cedex 1, 44093
FranceSite Not Available
Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert
Budapest, 1021
HungarySite Not Available
Bekes Megyei Pandy Kalman Korhaz
Gyula, 57--
HungarySite Not Available
Seoul National University Hospital
Seoul, Gyeonggi-do 110774
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju, 501-757
Korea, Republic ofSite Not Available
Inha University Hospital
Incheon, 400-711
Korea, Republic ofSite Not Available
Chonbuk National University Hospital
Jeonju, 561-712
Korea, Republic ofSite Not Available
Chonbuk National University Hospital
Jeonju-si, 561-712
Korea, Republic ofSite Not Available
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaSite Not Available
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacan, Sinaloa 80020
MexicoSite Not Available
Dr. Jessica Rosas Escobar
Durango, 34000
MexicoSite Not Available
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
MexicoSite Not Available
Instituto Nacional de Pediatria
Mexico, 04530
MexicoSite Not Available
Accelerium S. de R.L. de C.V.
Monterrey, 64000
MexicoSite Not Available
Instituto de Informacion de Investigacion en Salud Mental
Monterrey, 64710
MexicoSite Not Available
Av Modesto Arreola #917 Ote. Col Centro
Nuevo León, 64000
MexicoSite Not Available
Alexian Brothers Health and Wellness Center
Davao City, 8000
PhilippinesSite Not Available
West Visayas State University Medical Center
Iloilo, 5000
PhilippinesSite Not Available
West Visayas State University Medical Center
Iloilo City, 5000
PhilippinesSite Not Available
National Center for Mental Health
Mandaluyong City, 1553
PhilippinesSite Not Available
Veterans Memorial Medical Center
Quezon City, 1101
PhilippinesSite Not Available
NZOZ Poradnia Zdrowia Psychicznego
Kobierzyce, 55-040
PolandSite Not Available
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy
Toruń, 87-100
PolandSite Not Available
Centro de Investigacion Clinica Psiquiatrica
Caguas, 00725
Puerto RicoSite Not Available
INSPIRA Clinical Research
San Juan, 00918
Puerto RicoSite Not Available
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucuresti, 041914
RomaniaSite Not Available
Spitalul Clinic de Psihiatrie Socola
Iasi, 700282
RomaniaSite Not Available
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
Timisoara, 300239
RomaniaSite Not Available
Sverdiovsk Regional Clinical Psychiatric Hospital
Ekaterinburg, 62003
Russian FederationSite Not Available
GUZ Lipetsk Regional psychoneurological Hospital #1
Lipetsk, 399313
Russian FederationSite Not Available
GUZ Lipetsk Regional psychoneurological Hospital #1
Lipetsk region, 399313
Russian FederationSite Not Available
Closed corporation "Scientific Center of Personalized Psychiatry"
Moscow, 119180
Russian FederationSite Not Available
Scientific Center of Personalized Psychiatry
Moscow, 119180
Russian FederationSite Not Available
State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"
Nizhny Novgorod, 603155
Russian FederationSite Not Available
Bekhterev Institute
Saint Petersburg,
Russian FederationSite Not Available
Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin
Saint Petersburg, 197022
Russian FederationSite Not Available
SHI "City Psychoneurological dispensary #7 (with Hospital)"
Saint Petersburg, 190005
Russian FederationSite Not Available
Regional Clinical Mental Hospital of Saint Sofiya
Saratow, 410060
Russian FederationSite Not Available
FSBSI "Scientific Research Institute of Mental Health"
Tomsk, 634014
Russian FederationSite Not Available
State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"
Yaroslavl, 150003
Russian FederationSite Not Available
Hospital Marítimo de Torremolinos
Torremolinos, Málaga 29620
SpainSite Not Available
RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU
Ivano Frankivsk, 76014
UkraineSite Not Available
SI Institute of Children and Adolescents Healthcare of NAMSU
Kharkiv, 61153
UkraineSite Not Available
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, 61068
UkraineSite Not Available
CI Kherson Regional Psychiatric Hospital of Kherson RC
Kherson,Vil. Stepanivka, 73488
UkraineSite Not Available
TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
Kyiv, 04080
UkraineSite Not Available
CI Lviv Regional Clinical Psychiatric Hospital
Lviv, 79021
UkraineSite Not Available
Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
Odesa, 65014
UkraineSite Not Available
O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy
Poltava, 36006
UkraineSite Not Available
CI Kherson Regional Psychiatric Hospital of Kherson RC
Stepanivka, 73488
UkraineSite Not Available
Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU
Ternopil, 46020
UkraineSite Not Available
Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
Vinnitsia, 21018
UkraineSite Not Available
Harmonex Neuroscience Research
Dothan, Alabama 36303
United StatesSite Not Available
Southwest Autism Research & Resource Center
Phoenix, Arizona 85006
United StatesSite Not Available
ProScience Research Group
Culver City, California 90230
United StatesSite Not Available
Diligent Clinical Trials, Inc
Downey, California 90241
United StatesSite Not Available
Collaborative Neuroscience Network, LLC
Garden Grove, California 92845
United StatesSite Not Available
University of California San Francisco Medical Center
San Francisco, California 94143
United StatesSite Not Available
Neuropsychiatric Research Center of Orange County
Santa Ana, California 92701
United StatesSite Not Available
Florida Clinical Research Center, LLC
Bradenton, Florida 34201
United StatesSite Not Available
Sarkis Clinical Trials - Parent
Gainesville, Florida 32607
United StatesSite Not Available
Palm Springs Research Institute
Hialeah, Florida 33012
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256
United StatesSite Not Available
Florida Clinical Research Center, LLC
Maitland, Florida 32751
United StatesSite Not Available
APG Research, LLC
Orlando, Florida 32803
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
United StatesSite Not Available
University of South Florida
Saint Petersburg, Florida 33701
United StatesSite Not Available
Medical Research Group of Central Florida
Sanford, Florida 32771
United StatesSite Not Available
University of South Florida Rothman Center of Neuropychiatry
Tampa, Florida 33613
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30308
United StatesSite Not Available
Attalla Consultants, LLC
Smyrna, Georgia 30080
United StatesSite Not Available
Capstone Clinical Research, Inc.
Libertyville, Illinois 60048
United StatesSite Not Available
Baber Research Group
Naperville, Illinois 60563
United StatesSite Not Available
Psychiatric Associates
Overland Park, Kansas 66211
United StatesSite Not Available
University Of Kentucky
Lexington, Kentucky 40509
United StatesSite Not Available
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana 70601
United StatesSite Not Available
Kennedy Krieger Institute
Baltimore, Maryland 21205
United StatesSite Not Available
Neurobehaviorial Medicine Group, PLLC
Bloomfied Hills, Michigan 48302
United StatesSite Not Available
Neurobehavioral medicine Group, LLC
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
St. Charles Psychiatric Associates
Saint Charles, Missouri 63301
United StatesSite Not Available
St. Charles Psychiatric Associates
St. Charles, Missouri 63301
United StatesSite Not Available
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada 89128
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune City, New Jersey 07753
United StatesSite Not Available
Childrens Specialized Hospital
Toms River, New Jersey 08755
United StatesSite Not Available
North Shore/Long Island Jewish PRIME
Glen Oaks, New York 11004
United StatesSite Not Available
Dr. Jeanette Cueva
Mount Kisco, New York 10549
United StatesSite Not Available
Montefiore Medical Center PRIME
New York, New York 10467
United StatesSite Not Available
Finger Lakes Clinical Research
Rochester, New York 10618
United StatesSite Not Available
Richmond Behavioral Associates
Staten Island, New York 10312
United StatesSite Not Available
Chapel Hill Neurology
Chapel Hill, North Carolina 27517
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
University Hospitals Case Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University Nisonger Center
Columbus, Ohio 43210
United StatesSite Not Available
Cutting Edge Research Group
Oklahoma City, Oklahoma 73116
United StatesSite Not Available
Cyn3rgy Research & Development
Gresham, Oregon 97030
United StatesSite Not Available
Suburban Research Associates
Media, Pennsylvania 19603
United StatesSite Not Available
Segal Institute for Clinical Research
Charleston, South Carolina 29407
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United StatesSite Not Available
BioBehavioral Research of Austin
Austin, Texas 78759
United StatesSite Not Available
Pillar Clinical Research, LLC
Dallas, Texas 75243
United StatesSite Not Available
BioBehavioral Research of Austin
El Campo, Texas 77437
United StatesSite Not Available
Family Psychiatry of The Woodlands, P.A.
The Woodlands, Texas 77381
United StatesSite Not Available
Ericksen Research & Development, LLC
Clinton, Utah 84015
United StatesSite Not Available
Aspen Clinical Research
Orem, Utah 84058
United StatesSite Not Available
CRI Lifetree
Salt Lake City, Utah 84106
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
Neuroscience, Inc.
Herndon, Virginia 20170
United StatesSite Not Available
Clinical Research Partners, LLC
Petersburg, Virginia 23805
United StatesSite Not Available
Carilion Clinic
Roanoke, Virginia 24014
United StatesSite Not Available
Pacific Institute Of Medical Sciences
Bothell, Washington 98011
United StatesSite Not Available
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