Pediatric Schizophrenia Efficacy and Safety Study

NCT01911429 | Completed Phase 3 Results DMC

• 2 other identifiers: D10503012013-001695-38
• Study Type: interventional
• Target: 327
• Locations: 17 countries
• Sites: 90

Brief Summary

Efficacy and Safety study of Lurasidone in pediatric patients.

Conditions

Schizophrenia

Keywords

schizophrenia; Lurasidone; Latuda

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.

  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.

  Baseline to 6 weeks

Secondary Outcomes (8)

• Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale

  baseline, week 6

• Change From Baseline in PANSS Positive Subscale Scores

  baseline, week 6

• Change From Baseline in PANSS Positive, Negative Subscale Scores

  baseline, week 6

• Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6

  week 6

• Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)

  baseline, week 6

Study Arms (3)

Lurasidone 40 mg

EXPERIMENTAL

Lurasidone 40 mg once daily

Drug: Lurasidone 40 mg

Lurasidone 80 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo 40 or 80 mg once daily

Drug: Placebo 40 or 80 mg

Interventions

Lurasidone 40 mg DRUG

Lurasidone 40 mg once daily

Also known as: Latuda

Lurasidone 40 mg

Lurasidone 80 mg DRUG

Lurasidone 80 mg once daily

Also known as: Latuda

Lurasidone 80 mg

Placebo 40 or 80 mg DRUG

Placebo 40 or 80 mg once daily

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (90)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

California Pharmaceutical Research Institute, Inc

Anaheim, California, 92804, United States

Location

Central Valley Medical Research

Bakersfield, California, 93311, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Diligent Clinical Trials, Inc

Downey, California, 90241, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Global Clinical Trials, LLC

Irvine, California, 92614, United States

Location

Neuropsychiatric Research Center of Orange County

Orange, California, 92868, United States

Location

Asclepes Research

Panorama City, California, 91402, United States

Location

CITrials, Inc. - Riverside & San Bernardino County

Riverside, California, 92506, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34201, United States

Location

Sarkis Clinical Trials - Parent

Gainesville, Florida, 32607, United States

Location

APG Research, LLC

Orlando, Florida, 32803, United States

Location

Medical Research Group of Central Florida

Sanford, Florida, 32771, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Institute for Behavioral Medicine, LLC

Smyrna, Georgia, 30080, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, 70629, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Neurobehavioral Medicine Group, PLLC

Bloomfield Hills, Michigan, 48302, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Manhattan Behavioral Medicine, LLC

New York, New York, 10022, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Research Strategies of Memphis, LLC

Memphis, Tennessee, 38119, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

BioBehavioral Research of Austin

El Campo, Texas, 77437, United States

Location

Family Psychiatry of The Woodlands, P.A.

The Woodlands, Texas, 77381, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MHC - Ruse, EOOD

Rousse, 7003, Bulgaria

Location

UMHAT "Alexandrovska" EAD

Sofia, 1431, Bulgaria

Location

MHAT-Targovishte, AD

Targovishte, 7700, Bulgaria

Location

MHAT 'Sv. Marina', EAD

Varna, 9003, Bulgaria

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, Colombia

Location

E.S.E. Hospital Mental de Antioquia

Bello, 0000, Colombia

Location

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

Bogotá, 00000, Colombia

Location

CHU Nantes - Hôpital Mère-Enfant

Nantes, Loire Atlantique, 44093, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, 06200, France

Location

Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

Budapest, 1021, Hungary

Location

Bekes Megyei Pandy Kalman Korhaz

Gyula, 5700, Hungary

Location

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

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

Culiacán, 80020, Mexico

Location

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

Monterrey, 64000, Mexico

Location

Instituto de Informacion de Investigacion en Salud Mental

Monterrey, 64710, Mexico

Location

Alexian Brothers Health and Wellness Center

Daveo City, 8000, Philippines

Location

West Visayas State University Medical Center

Iloilo City, 5000, Philippines

Location

National Center for Mental Health

Mandaluyong, 1553, Philippines

Location

Veterans Memorial Medical Center

Quezon City, 1101, Philippines

Location

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, 87-100, Poland

Location

NZOZ Poradnia Zdrowia Psychicznego

Tyniec Mały, 55-040, Poland

Location

Instytut Psychiatrii i Neurologii

Warsaw, 02-957, Poland

Location

Centro de Investigacion Clinica Psiquiatrica

Caguas, 00725, Puerto Rico

Location

Centro de Investigacion Clinica Psiquiatrica

Ponce, 00731, Puerto Rico

Location

INSPIRA Clinical Research

San Juan, 00918, Puerto Rico

Location

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

Bucharest, 041914, Romania

Location

Spitalul Clinic de Psihiatrie Socola

Iași, 700282, Romania

Location

Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

Timișoara, 300239, Romania

Location

Regional Government Institution Kipetsk Regional Psychoneurology Hospital

Lipetsk, 399083, Russia

Location

St. Petersburg State Healthcare Institution (SPSHI)

Saint Petersburg, 190005, Russia

Location

FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

Saint Petersburg, 192019, Russia

Location

SHI Regional Clinical Psychiatry Hospital of St. Sofia

Saratov, 410060, Russia

Location

FSBSI "Scientific Research Institute of Mental Health"

Tomsk, 634014, Russia

Location

Nizhny Novgorod Regional State Institution of Healthcare

Veliky Novgorod, 603155, Russia

Location

Sverdlov regional Psychiatric Clinical Hospital

Yekaterinburg, 620030, Russia

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Hospital Marítimo de Torremolinos

Torremolinos, Málaga, 29620, Spain

Location

Hospital Sant Joan de Deu

Barcelona, 08950, Spain

Location

RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

Ivano-Frankivsk, 76014, Ukraine

Location

SI Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, 61068, Ukraine

Location

SI Institute of Children and Adolescents Healthcare of NAMSU

Kharkiv, 61153, Ukraine

Location

CI Kherson Regional Psychiatric Hospital of Kherson RC

Kherson,Vil. Stepanivka, 73488, Ukraine

Location

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

Kyiv, 04080, Ukraine

Location

CI Lviv Regional Clinical Psychiatric Hospital

Lviv, 79021, Ukraine

Location

CI Odesa Regional Medical Center of Mental Health

Odesa, 65006, Ukraine

Location

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

Poltava, 36006, Ukraine

Location

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

Ternopil, 46020, Ukraine

Location

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

Vinnytsia, 21005, Ukraine

Location

Royal Cornhill Hospital

Aberdeen, Strathclyde, AB25 2ZH, United Kingdom

Location

Northcroft

Birmingham, B23 6DW, United Kingdom

Location

Royal Edinburgh Hospital

Edinburgh, EH10 5HF, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialsdisclosure@sunovion.com

1-866-503-6351

Study Officials

• Lurasidone Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 30, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 18, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-03

Locations

CO (3); BU (4); BE (1); MY (1); PH (4); ME (3); PR (3); KR (3); UA (10); GB (3); FR (2); RO (3); US (36); RU (7); ES (2); PL (3); HU (2)