Pediatric Schizophrenia Efficacy and Safety Study

NCT ID: NCT01911429

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-12-31

Brief Summary

Efficacy and Safety study of Lurasidone in pediatric patients.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lurasidone 40 mg

Lurasidone 40 mg once daily

Group Type: EXPERIMENTAL

Lurasidone 40 mg

Intervention Type: DRUG

Lurasidone 40 mg once daily

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

Group Type: EXPERIMENTAL

Lurasidone 80 mg

Intervention Type: DRUG

Lurasidone 80 mg once daily

Placebo

Placebo 40 or 80 mg once daily

Group Type: PLACEBO_COMPARATOR

Placebo 40 or 80 mg

Intervention Type: DRUG

Placebo 40 or 80 mg once daily

Interventions

Lurasidone 40 mg

Lurasidone 40 mg once daily

Intervention Type: DRUG

Lurasidone 80 mg

Lurasidone 80 mg once daily

Intervention Type: DRUG

Placebo 40 or 80 mg

Placebo 40 or 80 mg once daily

Intervention Type: DRUG

Other Intervention Names

Latuda; Latuda

Eligibility 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).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lurasidone Medical Director

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Harmonex Neuroscience Research

Dothan, Alabama, United States

California Pharmaceutical Research Institute, Inc

Anaheim, California, United States

Central Valley Medical Research

Bakersfield, California, United States

ProScience Research Group

Culver City, California, United States

Diligent Clinical Trials, Inc

Downey, California, United States

Collaborative Neuroscience Network, LLC

Garden Grove, California, United States

Global Clinical Trials, LLC

Irvine, California, United States

Neuropsychiatric Research Center of Orange County

Orange, California, United States

Asclepes Research

Panorama City, California, United States

CITrials, Inc. - Riverside & San Bernardino County

Riverside, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Sarkis Clinical Trials - Parent

Gainesville, Florida, United States

APG Research, LLC

Orlando, Florida, United States

Medical Research Group of Central Florida

Sanford, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Institute for Behavioral Medicine, LLC

Smyrna, Georgia, United States

Baber Research Group

Naperville, Illinois, United States

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Neurobehavioral Medicine Group, PLLC

Bloomfield Hills, Michigan, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Manhattan Behavioral Medicine, LLC

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Research Strategies of Memphis, LLC

Memphis, Tennessee, United States

BioBehavioral Research of Austin

Austin, Texas, United States

Pillar Clinical Research, LLC

Dallas, Texas, United States

BioBehavioral Research of Austin

El Campo, Texas, United States

Family Psychiatry of The Woodlands, P.A.

The Woodlands, Texas, United States

Aspen Clinical Research

Orem, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Universitair Ziekenhuis Brussel

Brussels, , Belgium

MHC - Ruse, EOOD

Rousse, , Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, , Bulgaria

MHAT-Targovishte, AD

Targovishte, , Bulgaria

MHAT 'Sv. Marina', EAD

Varna, , Bulgaria

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, , Colombia

E.S.E. Hospital Mental de Antioquia

Bello, , Colombia

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

Bogotá, , Colombia

CHU Nantes - Hôpital Mère-Enfant

Nantes, Loire Atlantique, France

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, , France

Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

Budapest, , Hungary

Bekes Megyei Pandy Kalman Korhaz

Gyula, , Hungary

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

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

Culiacán, , Mexico

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

Monterrey, , Mexico

Instituto de Informacion de Investigacion en Salud Mental

Monterrey, , Mexico

Alexian Brothers Health and Wellness Center

Daveo City, , Philippines

West Visayas State University Medical Center

Iloilo City, , Philippines

National Center for Mental Health

Mandaluyong, , Philippines

Veterans Memorial Medical Center

Quezon City, , Philippines

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, , Poland

NZOZ Poradnia Zdrowia Psychicznego

Tyniec Mały, , Poland

Instytut Psychiatrii i Neurologii

Warsaw, , Poland

Centro de Investigacion Clinica Psiquiatrica

Caguas, , Puerto Rico

Centro de Investigacion Clinica Psiquiatrica

Ponce, , Puerto Rico

INSPIRA Clinical Research

San Juan, , Puerto Rico

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

Bucharest, , Romania

Spitalul Clinic de Psihiatrie Socola

Iași, , Romania

Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

Timișoara, , Romania

Regional Government Institution Kipetsk Regional Psychoneurology Hospital

Lipetsk, , Russia

St. Petersburg State Healthcare Institution (SPSHI)

Saint Petersburg, , Russia

FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

Saint Petersburg, , Russia

SHI Regional Clinical Psychiatry Hospital of St. Sofia

Saratov, , Russia

FSBSI "Scientific Research Institute of Mental Health"

Tomsk, , Russia

Nizhny Novgorod Regional State Institution of Healthcare

Veliky Novgorod, , Russia

Sverdlov regional Psychiatric Clinical Hospital

Yekaterinburg, , Russia

Inha University Hospital

Incheon, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hospital Marítimo de Torremolinos

Torremolinos, Málaga, Spain

Hospital Sant Joan de Deu

Barcelona, , Spain

RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

Ivano-Frankivsk, , Ukraine

SI Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, , Ukraine

SI Institute of Children and Adolescents Healthcare of NAMSU

Kharkiv, , Ukraine

CI Kherson Regional Psychiatric Hospital of Kherson RC

Kherson,Vil. Stepanivka, , Ukraine

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

Kyiv, , Ukraine

CI Lviv Regional Clinical Psychiatric Hospital

Lviv, , Ukraine

CI Odesa Regional Medical Center of Mental Health

Odesa, , Ukraine

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

Poltava, , Ukraine

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

Ternopil, , Ukraine

M.I. Pyrogov VNMU Ch of Psych&Nar BO CI O.I. Yuschenko VRPsH

Vinnytsia, , Ukraine

Royal Cornhill Hospital

Aberdeen, Strathclyde, United Kingdom

Northcroft

Birmingham, , United Kingdom

Royal Edinburgh Hospital

Edinburgh, , United Kingdom

Countries

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

Other Identifiers

2013-001695-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D1050301

Identifier Type: -

Identifier Source: org_study_id