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Trial record 94 of 3003 for:    Schizophrenia

Pediatric Schizophrenia Efficacy and Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01911429
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : March 22, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
Efficacy and Safety study of Lurasidone in pediatric patients.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone 40 mg Drug: Lurasidone 80 mg Drug: Placebo 40 or 80 mg Phase 3

Detailed Description:
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study To Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects With Schizophrenia
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: Lurasidone 40 mg
Lurasidone 40 mg once daily
Drug: Lurasidone 40 mg
Lurasidone 40 mg once daily
Other Name: Latuda

Experimental: Lurasidone 80 mg
Lurasidone 80 mg once daily Arm received the Lurasidone 40mg dose first, from Days 1-3, and then received the Lurasidone 80 mg dose from day 4 to Week 6
Drug: Lurasidone 80 mg
Lurasidone 80 mg once daily
Other Name: Latuda

Placebo Comparator: Placebo
Placebo 40 or 80 mg once daily
Drug: Placebo 40 or 80 mg
Placebo 40 or 80 mg once daily




Primary Outcome Measures :
  1. Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6. [ Time Frame: Baseline to 6 weeks ]

    PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction.



Secondary Outcome Measures :
  1. Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale [ Time Frame: baseline, week 6 ]

    Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients.

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction.


  2. Change From Baseline in PANSS Positive Subscale Scores [ Time Frame: baseline, week 6 ]

    PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures -Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.


  3. Change From Baseline in PANSS Positive, Negative Subscale Scores [ Time Frame: baseline, week 6 ]

    PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - - Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.


  4. Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6 [ Time Frame: week 6 ]
    PANSS responder analysis over time: achieving >= 20% reduction from baseline

  5. Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) [ Time Frame: baseline, week 6 ]

    PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.

    LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.


  6. Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) [ Time Frame: baseline, week 6 ]

    Clinician-rated Children's Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning

    LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.


  7. Change From Baseline in PANSS General Psychopathology Subscale Scores [ Time Frame: baseline, week 6 ]

    PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -- General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.


  8. Change From Baseline in PANSS Excitability Subscale Scores [ Time Frame: baseline, week 6 ]

    Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control

    • Higher values of PANSS Excitability Subscale Score represent greater severity of illness

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.




Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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' adherence to the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation.
  • Male or female subjects 13 to 17 years of age, inclusive, at the time of consent.
  • DSM-IV-TR axis I primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes) and confirmation of the schizophrenia diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL).
  • PANSS total score ≥ 70 at screening and Baseline.
  • CGI-S ≥ 4 at screening and Baseline.
  • Within 5th to 95th percentile for gender specific weight-for-age and height-for-age Growth Charts from National Center for Health Statistics.
  • In good physical health on the basis of medical history, physical examination, and laboratory screening.
  • 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 30 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 (e.g., 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 30 days after the last dose of study drug has been taken.
  • In the judgement of the clinician, the subject has an acute exacerbation of psychotic symptoms (no longer than 2 months in duration) and marked deterioration of function from baseline (by history) or, the subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
  • In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol.
  • Willing and able to adhere to protocol-specified meal requirements during dosing.

Exclusion Criteria:

  • Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
  • Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma.
  • Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
  • Any of the following:

Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome).

Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.

  • PANSS total scores ≥ 120 at screening or Baseline.
  • 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.
  • Lifetime history of electroconvulsive therapy (ECT).
  • Resistant to antipsychotic treatment based on at least two different prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of schizophrenia.
  • Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.

  • Has a history of malignancy < 5 years prior to signing the informed consent.
  • Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
  • Clinically relevant abnormal laboratory values or abnormal vital sign values/findings.

Note: If any laboratory results are outside the normal range, the site may have the subject retested. If upon retesting the value remains outside the normal range, the significance of this value must be discussed with the Medical Monitor for enrollment consideration.

  • A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Abnormal screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
  • Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
  • Clinically significant alcohol abuse/dependence or drug abuse/dependence based on DSM-IV-TR criteria within the last 6 months prior to screening.
  • Positive test results at screening or Baseline for:

    1. Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, and methadone). A positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol) or alcohol, the investigator will evaluate the subject's ability to abstain from prohibited substances during the study. If in the investigator's clinical judgment the subject will abstain, the subject may be enrolled after consultation with the Medical Monitor.
    2. Pregnancy test.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to randomization.
  • Donation of whole blood within 60 days prior to randomization.
  • Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes.
  • Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.
  • Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization.
  • Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer.
  • Received treatment with antidepressants, stimulants, or atomoxetine within 3 days prior to randomization, fluoxetine hydrochloride within 21 days of randomization, monoamine oxidase (MAO) inhibitor within 28 days of randomization, or clozapine within 120 days of randomization.
  • Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine, eslicarbazepine acetate, or fluvoxamine, within 3 days prior to randomization (7 days prior to randomization for aripiprazole) and until follow-up.
  • Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary adenoma.
  • At screening or Baseline the subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C-SSRS.
  • Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 3 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
  • Adhering to a special diet for the 28 days prior to drug administration (eg, liquid, protein, raw food diet).
  • Subject is planning to move during the study, is chronically homeless, or is unable to attend all planned study visits. The Medical Monitor will be consulted for individual cases, as needed.
  • Demonstrates a decrease (improvement) of > 25% in the PANSS score between screening and Baseline visits.
  • Subject with newly diagnosed Type 2 diabetes during screening. A subject with Type 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:

Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Retested fasted value cannot be ≥ 126 mg/dL.

HbA1c ≤ 6.5%; and If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.

  • Subject has required hospitalization for diabetes or related complications in the past 12 months.
  • Subject requires use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing informed consent until follow-up.
  • Clinically significant orthostatic hypotension (ie., a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911429


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Locations
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United States, Alabama
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, California
California Pharmaceutical Research Institute, Inc
Anaheim, California, United States, 92804
Central Valley Medical Research
Bakersfield, California, United States, 93311
ProScience Research Group
Culver City, California, United States, 90230
Diligent Clinical Trials, Inc
Downey, California, United States, 90241
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
Global Clinical Trials, LLC
Irvine, California, United States, 92614
Neuropsychiatric Research Center of Orange County
Orange, California, United States, 92868
Asclepes Research
Panorama City, California, United States, 91402
CITrials, Inc. - Riverside & San Bernardino County
Riverside, California, United States, 92506
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
Sarkis Clinical Trials - Parent
Gainesville, Florida, United States, 32607
APG Research, LLC
Orlando, Florida, United States, 32803
Medical Research Group of Central Florida
Sanford, Florida, United States, 32771
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, United States, 30080
United States, Illinois
Baber Research Group
Naperville, Illinois, United States, 60563
United States, Louisiana
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Michigan
Neurobehavioral Medicine Group, PLLC
Bloomfield Hills, Michigan, United States, 48302
United States, New Jersey
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
United States, New York
Manhattan Behavioral Medicine, LLC
New York, New York, United States, 10022
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
United States, Tennessee
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States, 38119
United States, Texas
BioBehavioral Research of Austin
Austin, Texas, United States, 78759
Pillar Clinical Research, LLC
Dallas, Texas, United States, 75243
BioBehavioral Research of Austin
El Campo, Texas, United States, 77437
Family Psychiatry of The Woodlands, P.A.
The Woodlands, Texas, United States, 77381
United States, Utah
Aspen Clinical Research
Orem, Utah, United States, 84058
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Belgium
Universitair Ziekenhuis Brussel
Bruxelles, Belgium, 1090
Bulgaria
MHC - Ruse, EOOD
Ruse, Bulgaria, 7003
UMHAT "Alexandrovska" EAD
Sofia, Bulgaria, 1431
MHAT-Targovishte, AD
Targovishte, Bulgaria, 7700
MHAT 'Sv. Marina', EAD
Varna, Bulgaria, 9003
Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, Colombia
E.S.E. Hospital Mental de Antioquia
Bello, Colombia, 0000
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogota, Colombia, 00000
France
CHU Nantes - Hôpital Mère-Enfant
Nantes Cedex 1, Loire Atlantique, France, 44093
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France, 06200
Hungary
Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert
Budapest, Hungary, 1021
Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary, 5700
Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Chonbuk National University Hospital
Jeonju-si, Korea, Republic of, 561-712
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacan, Mexico, 80020
Accelerium S. de R.L. de C.V.
Monterrey, Mexico, 64000
Instituto de Informacion de Investigacion en Salud Mental
Monterrey, Mexico, 64710
Philippines
Alexian Brothers Health and Wellness Center
Daveo City, Philippines, 8000
West Visayas State University Medical Center
Iloilo City, Philippines, 5000
National Center for Mental Health
Mandaluyong City, Philippines, 1553
Veterans Memorial Medical Center
Quezon City, Philippines, 1101
Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland, 87-100
NZOZ Poradnia Zdrowia Psychicznego
Tyniec Maly, Poland, 55-040
Instytut Psychiatrii i Neurologii
Warszawa, Poland, 02-957
Puerto Rico
Centro de Investigacion Clinica Psiquiatrica
Caguas, Puerto Rico, 00725
Centro de Investigacion Clinica Psiquiatrica
Ponce, Puerto Rico, 00731
INSPIRA Clinical Research
San Juan, Puerto Rico, 00918
Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucuresti, Romania, 041914
Spitalul Clinic de Psihiatrie Socola
Iasi, Romania, 700282
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
Timisoara, Romania, 300239
Russian Federation
Sverdlov regional Psychiatric Clinical Hospital
Ekaterinburg, Russian Federation, 620030
Regional Government Institution Kipetsk Regional Psychoneurology Hospital
Lipetsk, Russian Federation, 399083
Nizhny Novgorod Regional State Institution of Healthcare
Novgorod, Russian Federation, 603155
SHI Regional Clinical Psychiatry Hospital of St. Sofia
Saratov, Russian Federation, 410060
St. Petersburg State Healthcare Institution (SPSHI)
St. Petersburg, Russian Federation, 190005
FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"
St. Petersburg, Russian Federation, 192019
FSBSI "Scientific Research Institute of Mental Health"
Tomsk, Russian Federation, 634014
Spain
Hospital Marítimo de Torremolinos
Torremolinos, Málaga, Spain, 29620
Hospital Sant Joan de Deu
Barcelona, Spain, 08950
Ukraine
RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU
Ivano Frankivsk, Ukraine, 76014
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, Ukraine, 61068
SI Institute of Children and Adolescents Healthcare of NAMSU
Kharkiv, Ukraine, 61153
CI Kherson Regional Psychiatric Hospital of Kherson RC
Kherson,Vil. Stepanivka, Ukraine, 73488
TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
Kyiv, Ukraine, 04080
CI Lviv Regional Clinical Psychiatric Hospital
Lviv, Ukraine, 79021
CI Odesa Regional Medical Center of Mental Health
Odesa, Ukraine, 65006
O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy
Poltava, Ukraine, 36006
Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU
Ternopil, Ukraine, 46020
M.I. Pyrogov VNMU Ch of Psych&Nar BO CI O.I. Yuschenko VRPsH
Vinnytsia, Ukraine, 21005
United Kingdom
Royal Cornhill Hospital
Aberdeen, Strathclyde, United Kingdom, AB25 2ZH
Northcroft
Birmingham, United Kingdom, B23 6DW
Royal Edinburgh Hospital
Edinburgh, United Kingdom, EH10 5HF
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Lurasidone Medical Director Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01911429     History of Changes
Other Study ID Numbers: D1050301
2013-001695-38 ( EudraCT Number )
First Posted: July 30, 2013    Key Record Dates
Results First Posted: March 22, 2017
Last Update Posted: April 18, 2017
Last Verified: March 2017
Keywords provided by Sunovion:
schizophrenia
Lurasidone
Latuda
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental 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