Trial record 9 of 29 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 2016 by Sunovion
Information provided by (Responsible Party):
Sunovion Identifier:
First received: July 30, 2013
Last updated: July 6, 2016
Last verified: July 2016
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
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


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts 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.
  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 identifier: NCT01914393

Contact: Medical Director 1-866-503-6351

  Hide Study Locations
United States, Alabama
Harmonex Neuroscience Research Recruiting
Dothan, Alabama, United States, 36303
Contact: Nelson Handel, MD    334-836-2000   
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   
Principal Investigator: Marina Bussel, MD         
Diligent Clinical Trials, Inc Recruiting
Downey, California, United States, 90241
Contact: Elizabeth Zarate-Powell, MD    562-622-0700   
Principal Investigator: Elizabeth Zarate-Powell, MD         
Collaborative Neuroscience Network, LLC Recruiting
Garden Grove, California, United States, 92845
Contact: David Walling, MD    714-799-7799   
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   
Principal Investigator: Jose Zaglul, MD         
Sarkis Clinical Trials - Parent Recruiting
Gainesville, Florida, United States, 32607
Contact: Elias Sarkis, MD    352-333-0094   
Principal Investigator: Elias Sarkis, MD         
Palm Springs Research Institute Active, not recruiting
Hialeah, Florida, United States, 33012
Clinical Neuroscience Solutions, Inc. Completed
Jacksonville, Florida, United States, 32256
Florida Clinical Research Center, LLC Active, not recruiting
Maitland, Florida, United States, 32751
Clinical Neuroscience Solutions, Inc. Active, not recruiting
Orlando, Florida, United States, 32801
APG Research, LLC Recruiting
Orlando, Florida, United States, 32803
Contact: Morteza Nadjafi, MD    407-423-7149   
Principal Investigator: Morteza Nadjafi, MD         
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   
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   
Principal Investigator: Robert Reisenberg, MD         
Attalla Consultants, LLC Recruiting
Smyrna, Georgia, United States, 30080
Contact: Ashraf Attalla, MD    770-319-8025   
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   
Principal Investigator: Michael Greenbaum, MD         
Baber Research Group Recruiting
Naperville, Illinois, United States, 60563
Contact: Riaz Baber, MD    630-844-2095   
Principal Investigator: Riaz Baber, MD         
United States, Kansas
Psychiatric Associates Recruiting
Overland Park, Kansas, United States, 66211
Contact: William Murphy, MD    913-438-8221   
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   
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   
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   
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   
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   
Principal Investigator: Vivian Kafantares, MD         
Manhattan Behavioral Medicine, LLC Recruiting
New York, New York, United States, 10022
Contact: Gianni Faedda, MD    212-644-3111   
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   
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   
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   
Principal Investigator: Melissa DelBello, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nora McNamara, MD    216-844-5295   
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   
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   
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   
Principal Investigator: Divyansu Patel, MD         
Pillar Clinical Research, LLC Recruiting
Dallas, Texas, United States, 75243
Contact: Scott Bartley, MD    214-388-6455   
Principal Investigator: Scott Bartley, MD         
BioBehavioral Research of Austin Recruiting
El Campo, Texas, United States, 77437
Contact: Charles Sweet, MD    979-320-6173   
Principal Investigator: Charles Sweet, MD         
Family Psychiatry of The Woodlands, P.A. Recruiting
The Woodlands, Texas, United States, 77381
Contact: Marshall Lucas, MD    281-367-1015   
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   
Principal Investigator: Samantha Bostrom, MD         
Aspen Clinical Research Completed
Orem, Utah, United States, 84058
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   
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   
Principal Investigator: Syed Mustafa, MD         
MHC - Ruse, EOOD Recruiting
Ruse, Bulgaria, 7003
Contact: Bilyana Mechkunova, MD    +359878435022   
Principal Investigator: Bilyana Mechkunova, MD         
UMHAT "Alexandrovska" EAD Recruiting
Sofia, Bulgaria, 1431
Contact: Anton Slavchev, MD    +35929230644   
Principal Investigator: Anton Slavchev, MD         
MHAT-Targovishte, AD Recruiting
Targovishte, Bulgaria, 7700
Contact: Veselka Vasileva, MD    +35960178621   
Principal Investigator: Veselka Vasileva, MD         
DCC "Mladost M" - Varna, OOD Recruiting
Varna, Bulgaria, 9020
Contact: Petar Petrov, MD    +35952978472   
Principal Investigator: Petar Petrov, MD         
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Recruiting
Barranquilla, Colombia
Contact: Astrid Isabel Arrieta Molinares, MD    +5753738832   
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   
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   
Principal Investigator: Rodrigo Nel Cordoba Rojas, MD         
CHU Nantes - Hôpital Mère-Enfant Recruiting
Nantes Cedex 1, France, 44093
Contact: Olivier Bonnot, MD    +33240083667   
Principal Investigator: Olivier Bonnot, MD         
Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert Recruiting
Budapest, Hungary, 1021
Contact: Peter Nagy, MD    +3613921408   
Principal Investigator: Peter Nagy, MD         
Bekes Megyei Pandy Kalman Korhaz Recruiting
Gyula, Hungary, 57--
Contact: Magdolna Gacser, MD   
Principal Investigator: Magdolna Gacser, MD         
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 110774
Contact: Boon-Nyun Kim, MD    +82220722234   
Principal Investigator: Boon-Nyun Kim, MD         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Jai-Min Kim, MD    +82622206143   
Principal Investigator: Jai-Min Kim, MD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-711
Contact: Jeong-Seop Lee, MD    +82318903474   
Principal Investigator: Jeong-Seop Lee, MD         
Chonbuk National University Hospital Recruiting
Jeonju-si, Korea, Republic of, 561-712
Contact: Tae Won Park, MD    +82632501115   
Principal Investigator: Tae Won Park, MD         
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Subash Kumar Pillai Subramaniam, MD    +60379502068   
Principal Investigator: Subash Kumar Pillai Subramaniam, MD         
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   
Principal Investigator: Maria Luisa Moya Palazuelos, MD         
Accelerium S. de R.L. de C.V. Recruiting
Monterrey, Mexico, 64000
Contact: Federico Ramos-Ruiz, MD    +528155158000   
Principal Investigator: Federico Ramos-Ruiz, MD         
Instituto de Informacion de Investigacion en Salud Mental Recruiting
Monterrey, Mexico, 64710
Contact: Jose Alfonso Ontiveros Sanchez de la Barquera, MD    +528183330765   
Principal Investigator: Jose Alfonso Ontiveros Sanchez de la Barquera, MD         
Alexian Brothers Health and Wellness Center Recruiting
Davao City, Philippines, 8000
Contact: Marilou Benignas, MD    +63822972499   
Principal Investigator: Marilou Benignas, MD         
West Visayas State University Medical Center Recruiting
Iloilo City, Philippines, 5000
Contact: Japhet Fernandez De Leon, MD    +63333202431   
Principal Investigator: Japhet Fernandez De Leon, MD         
National Center for Mental Health Recruiting
Mandaluyong City, Philippines, 1553
Contact: Aida Muncada, MD    +6325319001   
Principal Investigator: Aida Muncada, MD         
Veterans Memorial Medical Center Recruiting
Quezon City, Philippines, 1101
Contact: Georgina Gozo-Oliver, MD    +639178521791   
Principal Investigator: Georgina Gozo-Oliver, MD         
NZOZ Poradnia Zdrowia Psychicznego Recruiting
Kobierzyce, Poland, 55-040
Contact: Halina Flisiak-Antonijczuk, MD    +48713501730ext55   
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   
Principal Investigator: Jorge Matta-Gonzalez, MD         
INSPIRA Clinical Research Recruiting
San Juan, Puerto Rico, 00918
Contact: Yvette Cruz, MD    787-753-9515   
Principal Investigator: Yvette Cruz         
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia Recruiting
Bucuresti, Romania, 041914
Contact: Iuliana Dobrescu, MD    +40213344266   
Principal Investigator: Iuliana Dobrescu         
Spitalul Clinic de Psihiatrie Socola Recruiting
Iasi, Romania, 700282
Contact: Carmen Gabriela Lupusoru, MD    +40740825121   
Principal Investigator: Carmen Gabriela Lupusoru, MD         
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara Recruiting
Timisoara, Romania, 300239
Contact: Liliana Nussbaum, MD    +40723659056   
Principal Investigator: Liliana Nussbaum, MD         
Russian Federation
GUZ Lipetsk Regional psychoneurological Hospital #1 Recruiting
Lipetsk region, Russian Federation, 399313
Contact: Andrey Gribanov, MD    +74742284115   
Principal Investigator: Andrey Gribanov, MD         
FSBSI "Scientific Research Institute of Mental Health" Recruiting
Tomsk, Russian Federation, 634014
Contact: Alexey Agarkov, MD    +79039550895   
Principal Investigator: Alexey Agarkov, MD         
Hospital Marítimo de Torremolinos Completed
Torremolinos, Málaga, Spain, 29620
RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU Recruiting
Ivano Frankivsk, Ukraine, 76014
Contact: Mykhaylo Vinnyk, MD    +380342774968   
Principal Investigator: Mykhaylo Vinnyk, MD         
SI Institute of Neurology, Psychiatry and Narcology of NAMSU Recruiting
Kharkiv, Ukraine, 61068
Contact: Valeriy Pidkorytov, MD    +380577716865   
Principal Investigator: Valeriy Pidkorytov, MD         
SI Institute of Children and Adolescents Healthcare of NAMSU Recruiting
Kharkiv, Ukraine, 61153
Contact: Tetyana Proskurina, MD    +380572624147   
Principal Investigator: Tetyana Proskurina, MD         
CI Kherson Regional Psychiatric Hospital of Kherson RC Recruiting
Kherson,Vil. Stepanivka, Ukraine, 73488
Contact: Pavlo Palamarchuk, MD    +380552543700   
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   
Principal Investigator: Yuliya Blazhevych, MD         
CI Lviv Regional Clinical Psychiatric Hospital Recruiting
Lviv, Ukraine, 79021
Contact: Oleksandr Filts, MD    +380322646573   
Principal Investigator: Oleksandr Filts, MD         
Odesa Regional Psychoneurological Dispensary, Outpatient Dept. Recruiting
Odesa, Ukraine, 65014
Contact: Anatolii Voloshchuk, MD    38 063 735 65 55   
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   
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   
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   
Principal Investigator: Sofiya Rymsha, MD         
Sponsors and Collaborators
Study Director: Lurasidone Medical Director, MD Sunovion
  More Information

Responsible Party: Sunovion Identifier: NCT01914393     History of Changes
Other Study ID Numbers: D1050302  2013-001694-24 
Study First Received: July 30, 2013
Last Updated: July 6, 2016
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:

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on August 25, 2016