Trial record 7 of 22 for:    neurology AND University AND San Francisco | Open Studies | Exclude Unknown

Pediatric Open-Label Extension Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Sunovion
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01914393
First received: July 30, 2013
Last updated: July 13, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention Phase
Schizophrenia
Autism
Bipolar Depression
Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Laboratory tests [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Tanner staging, and menstrual cyclicity (female subjects) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Vital Signs [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
    Vital signs following 5 minutes of seated rest will consist of supine systolic and diastolic blood pressures, respiration rate, heart rate, and oral body temperature.

  • Change in Body weight and body mass index [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Physical Examination [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
    The physical examination includes an assessment of general appearance and a review of systems (dermatologic, head, eyes, ears, nose, mouth/throat/neck, thyroid, lymph nodes, respiratory, cardiovascular, gastrointestinal, extremities, musculoskeletal, neurologic, and psychiatric systems).

  • Change in height (as measured by stadiometer) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in electrocardiogram [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
    All ECGs will be obtained in the supine position, after the subject has been resting supine for at least 10 minutes.


Secondary Outcome Measures:
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • CogState Computerized Cognitive Test Battery [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Clinician-rated Children's Global Assessment Scale (CGAS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist (ABC) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Children's Yale-Brown Obsessive Compulsive Scales [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Caregiver Strain Questionnaire (CGSQ) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 295
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily
Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
Other Name: Latuda

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914393

Contacts
Contact: Medical Director 1-866-503-6351

  Hide Study Locations
Locations
United States, Alabama
Harmonex Neuroscience Research Recruiting
Dothan, Alabama, United States, 36303
Contact: Nelson Handel, MD    334-836-2000    nhandal@harmonex.us   
Principal Investigator: Nelson Handel, MD         
United States, Arizona
Southwest Autism Research & Resource Center Active, not recruiting
Phoenix, Arizona, United States, 85006
United States, California
ProScience Research Group Recruiting
Culver City, California, United States, 90230
Contact: Marina Bussel, MD    424-227-8127    marina.bussel@prosciencerg.com   
Principal Investigator: Marina Bussel, MD         
Diligent Clinical Trials, Inc Recruiting
Downey, California, United States, 90241
Contact: Elizabeth Zarate-Powell, MD    562-622-0700    elizabethrowellmd@diligentclinicaltrials.com   
Principal Investigator: Elizabeth Zarate-Powell, MD         
Collaborative Neuroscience Network, LLC Recruiting
Garden Grove, California, United States, 92845
Contact: David Walling, MD    714-799-7799    davidwalling@cnstrial.com   
Principal Investigator: David Walling, MD         
University of California San Francisco Medical Center Active, not recruiting
San Francisco, California, United States, 94143
University of California San Francisco Medical Center Completed
San Francisco, California, United States, 94143
Neuropsychiatric Research Center of Orange County Recruiting
Santa Ana, California, United States, 92701
Contact: Daniel Chueh, MD         
Principal Investigator: Daniel Chueh, MD         
United States, Florida
Florida Clinical Research Center, LLC Recruiting
Bradenton, Florida, United States, 34201
Contact: Jose Zaglul, MD    941-747-7900    jzaglul@flcrc.com   
Principal Investigator: Jose Zaglul, MD         
Sarkis Clinical Trials - Parent Recruiting
Gainesville, Florida, United States, 32607
Contact: Elias Sarkis, MD    352-333-0094    ok@ehsfamily.com   
Principal Investigator: Elias Sarkis, MD         
Palm Springs Research Institute Active, not recruiting
Hialeah, Florida, United States, 33012
Clinical Neuroscience Solutions, Inc. Active, not recruiting
Jacksonville, Florida, United States, 32256
Florida Clinical Research Center, LLC Active, not recruiting
Maitland, Florida, United States, 32751
APG Research, LLC Recruiting
Orlando, Florida, United States, 32803
Contact: Morteza Nadjafi, MD    407-423-7149    morinadjafi@aol.com   
Principal Investigator: Morteza Nadjafi, MD         
Clinical Neuroscience Solutions, Inc. Active, not recruiting
Orlando, Florida, United States, 32801
University of South Florida Completed
Saint Petersburg, Florida, United States, 33701
Medical Research Group of Central Florida Recruiting
Sanford, Florida, United States, 32771
Contact: Adly Thebaud, MD    386-775-7627    athebaud@mrgcf.com   
Principal Investigator: Adly Thebaud, MD         
University of South Florida Rothman Center of Neuropychiatry Active, not recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30308
Contact: Robert Riesenberg, MD    404-881-5800    rriesenberg@acmr.org   
Principal Investigator: Andro Giorgadze, MD         
Attalla Consultants, LLC Recruiting
Smyrna, Georgia, United States, 30080
Contact: Ashraf Attalla, MD    770-319-8025    pi@drashrafattalla.com   
Principal Investigator: Ashraf Attalla, MD         
United States, Illinois
Capstone Clinical Research, Inc. Recruiting
Libertyville, Illinois, United States, 60048
Contact: Michael Greenbaum, MD    847-549-7214    mgreenbaum@capstoneclinical.com   
Principal Investigator: Michael Greenbaum, MD         
Baber Research Group Recruiting
Naperville, Illinois, United States, 60563
Contact: Riaz Baber, MD    630-844-2095    freeda@baberresearchgroup.com   
Principal Investigator: Riaz Baber, MD         
United States, Kansas
Psychiatric Associates Recruiting
Overland Park, Kansas, United States, 66211
Contact: William Murphy, MD    913-438-8221    research@murphyclinic.com   
Principal Investigator: William Murphy, MD         
United States, Kentucky
University Of Kentucky Completed
Lexington, Kentucky, United States, 40509
United States, Louisiana
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Kasinath G Yadalam, MD    337-494-3266    yadalam@aol.com   
Principal Investigator: Kasinath G Yadalam, MD         
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Robert Findling, MD    443-923-7620    rfindli1@jhmi.edu   
Principal Investigator: Robert Findling, MD         
United States, Michigan
Neurobehaviorial Medicine Group, PLLC Active, not recruiting
Bloomfied Hills, Michigan, United States, 48302
United States, Missouri
St. Charles Psychiatric Associates Recruiting
St. Charles, Missouri, United States, 63301
Contact: Richard Anderson, MD    636-946-8032    richardanderson@mac.com   
Principal Investigator: Richard Anderson, MD         
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc. Completed
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Contact: Ramon Solhkhah, MD    732-643-4402    rsolhkhah@meridianhealth.com   
Principal Investigator: Ramon Solhkhah, MD         
Childrens Specialized Hospital Completed
Toms River, New Jersey, United States, 08755
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Glen Oaks, New York, United States, 11004
Contact: Vivian Kafantares, MD    718-470-3503    vkafanta@lij.edu   
Principal Investigator: Vivian Kafantares, MD         
Manhattan Behavioral Medicine, LLC Recruiting
New York, New York, United States, 10022
Contact: Gianni Faedda, MD    212-644-3111    manhattanbehavioralmedicine@gmail.com   
Principal Investigator: Gianni Faedda, MD         
Montefiore Medical Center PRIME Active, not recruiting
New York, New York, United States, 10467
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 10618
Contact: Sarah Atkinson, MD    585-241-9670    sda@flclinical.com   
Principal Investigator: Sarah Atkinson, MD         
Richmond Behavioral Associates Active, not recruiting
Staten Island, New York, United States, 10312
United States, North Carolina
Chapel Hill Neurology Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Linmarie Sikich, MD    919-972-7500    lsikich@med.unc.edu   
Principal Investigator: Linmarie Sikich, MD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Melissa DelBello, MD    513-245-3415    delbelmp@email.uc.edu   
Principal Investigator: Melissa DelBello, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nora McNamara, MD    216-844-5295    nora.mcnamara@uhhospitals.org   
Principal Investigator: Nora McNamara, MD         
The Ohio State University Nisonger Center Completed
Columbus, Ohio, United States, 43210
United States, Oklahoma
Cutting Edge Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73116
Contact: Willis Holloway, MD    405-603-8068    wholloway@cuttingedgeresearch.org   
Principal Investigator: Willis Holloway, MD         
United States, Oregon
Cyn3rgy Research & Development Active, not recruiting
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Suburban Research Associates Active, not recruiting
Media, Pennsylvania, United States, 19603
United States, South Carolina
Segal Institute for Clinical Research Completed
Charleston, South Carolina, United States, 29407
United States, Tennessee
Clinical Neuroscience Solutions, Inc. Active, not recruiting
Memphis, Tennessee, United States, 38119
Research Strategies of Memphis, LLC Recruiting
Memphis, Tennessee, United States, 38119
Contact: Anita Varma, MD    901-685-8890    varmamd@researchmemphis.com   
Principal Investigator: Anita Varma, MD         
United States, Texas
BioBehavioral Research of Austin Recruiting
Austin, Texas, United States, 78759
Contact: Divyansu Patel, MD    512-382-6661    patel@bbraustin.com   
Principal Investigator: Divyansu Patel, MD         
Pillar Clinical Research, LLC Recruiting
Dallas, Texas, United States, 75243
Contact: Scott Bartley, MD    214-388-6455    sbartley@pillarhc.com   
Principal Investigator: Scott Bartley, MD         
Family Psychiatry of The Woodlands, P.A. Recruiting
The Woodlands, Texas, United States, 77381
Contact: Marshall Lucas, MD    281-367-1015    mlucasmd2011@hotmail.com   
Principal Investigator: Marshall Lucas, MD         
United States, Utah
Ericksen Research & Development, LLC Recruiting
Clinton, Utah, United States, 84015
Contact: Samantha Bostrom, MD    801-614-5501    amy-kim@westsidemedical.org   
Principal Investigator: Samantha Bostrom, MD         
Aspen Clinical Research Recruiting
Orem, Utah, United States, 84058
Contact: Michael Harris, MD    801-356-5555    drmharris@aspclinic.com   
Principal Investigator: Michael Harris, MD         
CRI Lifetree Active, not recruiting
Salt Lake City, Utah, United States, 84106
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Vishal Madaan, MD    434-243-6950    vm8d@virginia.edu   
Principal Investigator: Vishal Madaan, MD         
Neuroscience, Inc. Completed
Herndon, Virginia, United States, 20170
Clinical Research Partners, LLC Active, not recruiting
Petersburg, Virginia, United States, 23805
Carilion Clinic Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Pacific Institute Of Medical Sciences Recruiting
Bothell, Washington, United States, 98011
Contact: Syed Mustafa, MD    425-949-5779    souad@pspc.org   
Principal Investigator: Syed Mustafa, MD         
Bulgaria
MHC - Ruse, EOOD Recruiting
Ruse, Bulgaria, 7003
Contact: Bilyana Mechkunova, MD    +359878435022    bmechkunova@yahoo.com   
Principal Investigator: Bilyana Mechkunova, MD         
UMHAT "Alexandrovska" EAD Recruiting
Sofia, Bulgaria, 1431
Contact: Anton Slavchev, MD    +35929230644    anton.slavchev@gmail.com   
Principal Investigator: Anton Slavchev, MD         
MHAT-Targovishte, AD Recruiting
Targovishte, Bulgaria, 7700
Contact: Veselka Vasileva, MD    +35960178621    vesi_vasileva2002@yahoo.com   
Principal Investigator: Veselka Vasileva, MD         
DCC "Mladost M" - Varna, OOD Recruiting
Varna, Bulgaria, 9020
Contact: Petar Petrov, MD    +35952978472    pmdown@abv.bg   
Principal Investigator: Petar Petrov, MD         
Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Recruiting
Barranquilla, Colombia
Contact: Astrid Isabel Arrieta Molinares, MD    +5753738832    astridisabel1@gmail.com   
Principal Investigator: Astrid Isabel Arrieta Molinares, MD         
E.S.E. Hospital Mental de Antioquia Recruiting
Bello, Colombia, 0000
Contact: Lina Maria Agudelo Baeno, MD    +5744542323    lina.maria.agudelo@hotmail.com   
Principal Investigator: Lina Maria Agudelo Baeno, MD         
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda Recruiting
Bogota, Colombia, 00000
Contact: Rodrigo Nel Cordoba Rojas, MD    +5716700923    rodrigo.cordoba@grupocisne.org   
Principal Investigator: Rodrigo Nel Cordoba Rojas, MD         
France
CHU Nantes - Hôpital Mère-Enfant Recruiting
Nantes Cedex 1, France, 44093
Contact: Olivier Bonnot, MD    +33240083667    olivier.bonnot@chu-nantes.fr   
Principal Investigator: Olivier Bonnot, MD         
Hungary
Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert Recruiting
Budapest, Hungary, 1021
Contact: Peter Nagy, MD    +3613921408    nagypet01@gmail.com   
Principal Investigator: Peter Nagy, MD         
Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Jai-Min Kim, MD    +82622206143    jmkim@chonnam.ac.kr   
Principal Investigator: Jai-Min Kim, MD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-711
Contact: Jeong-Seop Lee, MD    +82318903474    soulfree@inha.ac.kr   
Principal Investigator: Jeong-Seop Lee, MD         
Chonbuk National University Hospital Recruiting
Jeonju-si, Korea, Republic of, 561-712
Contact: Tae Won Park, MD    +82632501115    ptaewon@jbnu.ac.kr   
Principal Investigator: Tae Won Park, MD         
Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Subash Kumar Pillai Subramaniam, MD    +60379502068    subashkumar70@gmail.com   
Principal Investigator: Subash Kumar Pillai Subramaniam, MD         
Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. Recruiting
Culiacan, Sinaloa, Mexico, 80020
Contact: Maria Luisa Moya Palazuelos, MD    +526677215355    mluisamoya@yahoo.com.mx   
Principal Investigator: Maria Luisa Moya Palazuelos, MD         
Instituto de Informacion de Investigacion en Salud Mental Recruiting
Monterrey, Mexico, 64710
Contact: Jose Alfonso Ontiveros Sanchez de la Barquera, MD    +528183330765    aonti@hotmail.com   
Principal Investigator: Jose Alfonso Ontiveros Sanchez de la Barquera, MD         
Poland
NZOZ Poradnia Zdrowia Psychicznego Recruiting
Kobierzyce, Poland, 55-040
Contact: Halina Flisiak-Antonijczuk, MD    +48713501730ext55    halina.flisiak@nzozpzp.pl   
Principal Investigator: Halina Flisiak-Antonijczuk, MD         
Puerto Rico
Centro de Investigacion Clinica Psiquiatrica Recruiting
Caguas, Puerto Rico, 00725
Contact: Jorge Matta-Gonzalez, MD    787-744-0857    drjmatta@yahoo.com   
Principal Investigator: Jorge Matta-Gonzalez, MD         
INSPIRA Clinical Research Recruiting
San Juan, Puerto Rico, 00918
Contact: Yvette Cruz, MD    787-753-9515    yvette_marie_cru@hotmail.com   
Principal Investigator: Yvette Cruz         
Romania
Spitalul Clinic de Psihiatrie Socola Recruiting
Iasi, Romania, 700282
Contact: Carmen Gabriela Lupusoru, MD    +40740825121    carmen_gab@yahoo.com   
Principal Investigator: Carmen Gabriela Lupusoru, MD         
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara Recruiting
Timisoara, Romania, 300239
Contact: Liliana Nussbaum, MD    +40723659056    nussbaumlaura@yahoo.com   
Principal Investigator: Liliana Nussbaum, MD         
Spain
Hospital Marítimo de Torremolinos Recruiting
Torremolinos, Málaga, Spain, 29620
Contact: Isabel Hernandez Otero, MD    +34951033766    isabelhotero@hotmail.com   
Principal Investigator: Isabel Hernandez Otero, MD         
Ukraine
RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU Recruiting
Ivano Frankivsk, Ukraine, 76014
Contact: Mykhaylo Vinnyk, MD    +380342774968    mishailvinnik@rambler.ru   
Principal Investigator: Mykhaylo Vinnyk, MD         
SI Institute of Children and Adolescents Healthcare of NAMSU Recruiting
Kharkiv, Ukraine, 61153
Contact: Tetyana Proskurina, MD    +380572624147    s.d.pro@mail.ru   
Principal Investigator: Tetyana Proskurina, MD         
SI Institute of Neurology, Psychiatry and Narcology of NAMSU Recruiting
Kharkiv, Ukraine, 61068
Contact: Valeriy Pidkorytov, MD    +380577716865    pid-vs@ukr.net   
Principal Investigator: Valeriy Pidkorytov, MD         
CI Kherson Regional Psychiatric Hospital of Kherson RC Recruiting
Kherson,Vil. Stepanivka, Ukraine, 73488
Contact: Pavlo Palamarchuk, MD    +380552543700    pavel.palamarchuk@mental.kherson.ua   
Principal Investigator: Pavlo Palamarchuk, MD         
TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions Recruiting
Kyiv, Ukraine, 04080
Contact: Yuliya Blazhevych, MD    +380444684147    blazhevych@ukr.net   
Principal Investigator: Yuliya Blazhevych, MD         
CI Lviv Regional Clinical Psychiatric Hospital Recruiting
Lviv, Ukraine, 79021
Contact: Oleksandr Filts, MD    +380322646573    filz_uuap@mail.lviv.ua   
Principal Investigator: Oleksandr Filts, MD         
Odesa Regional Psychoneurological Dispensary, Outpatient Dept. Recruiting
Odesa, Ukraine, 65014
Contact: Anatolii Voloshchuk, MD    38 063 735 65 55    voloshchuk@smo-ukraine.com   
Principal Investigator: Anatolii Voloshchuk, MD         
O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy Recruiting
Poltava, Ukraine, 36006
Contact: Andrii Skrypnikov, MD    +380532527755    psych74@mail.ru   
Principal Investigator: Andrii Skrypnikov, MD         
Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU Recruiting
Ternopil, Ukraine, 46020
Contact: Olena Venger, MD    +380352435771    op_venger@mail.ru   
Principal Investigator: Olena Venger, MD         
Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI Recruiting
Vinnitsia, Ukraine, 21018
Contact: Sofiya Rymsha, MD    380 432 554707    srymsha@rambler.ru   
Principal Investigator: Sofiya Rymsha, MD         
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Lurasidone Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01914393     History of Changes
Other Study ID Numbers: D1050302, 2013-001694-24
Study First Received: July 30, 2013
Last Updated: July 13, 2015
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Italy: The Italian Medicines Agency
Serbia: Medicines and Medical Devices Agency
Bulgaria: Bulgarian Drug Agency
Colombia: National Institutes of Health
China: Ministry of Health
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Philippines : Food and Drug Administration
Mexico: Ministry of Health

Keywords provided by Sunovion:
Schizophrenia
Autism
Lurasidone
Latuda

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 04, 2015