AzTrials
AzTrials

SchizophreniaPhase 3NCT01911429

Pediatric Schizophrenia Efficacy and Safety Study

A Phase 3 study testing Lurasidone 40 mg and Lurasidone 80 mg in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 90 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Efficacy and Safety study of Lurasidone in pediatric patients. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Schizophrenia
What is being tested?
Lurasidone 40 mg and Lurasidone 80 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
327 participants
Where
90 sitesin 17 countries
Study dates
Aug 2013to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.
Show all 43Show fewer
  • 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:
  • 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.
  • 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).

Trial locations and contacts

90 sites in 17 countries.

90 sites in 17 countries

United States36 sites

  • California Pharmaceutical Research Institute, Inc

    Anaheim, California, 92804

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

  • Central Valley Medical Research

    Bakersfield, California, 93311

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205

  • Neurobehavioral Medicine Group, PLLC

    Bloomfield Hills, Michigan, 48302

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • ProScience Research Group

    Culver City, California, 90230

  • Pillar Clinical Research, LLC

    Dallas, Texas, 75243

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Diligent Clinical Trials, Inc

    Downey, California, 90241

  • BioBehavioral Research of Austin

    El Campo, Texas, 77437

  • Sarkis Clinical Trials - Parent

    Gainesville, Florida, 32607

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Global Clinical Trials, LLC

    Irvine, California, 92614

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana, 70629

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • Baber Research Group

    Naperville, Illinois, 60563

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Manhattan Behavioral Medicine, LLC

    New York, New York, 10022

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Neuropsychiatric Research Center of Orange County

    Orange, California, 92868

  • Aspen Clinical Research

    Orem, Utah, 84058

  • APG Research, LLC

    Orlando, Florida, 32803

  • Asclepes Research

    Panorama City, California, 91402

  • CITrials, Inc. - Riverside & San Bernardino County

    Riverside, California, 92506

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Medical Research Group of Central Florida

    Sanford, Florida, 32771

  • Institute for Behavioral Medicine, LLC

    Smyrna, Georgia, 30080

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Family Psychiatry of The Woodlands, P.A.

    The Woodlands, Texas, 77381

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Ukraine10 sites

  • RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

    Ivano-Frankivsk, 76014

  • SI Institute of Neurology, Psychiatry and Narcology of NAMSU

    Kharkiv, 61068

  • SI Institute of Children and Adolescents Healthcare of NAMSU

    Kharkiv, 61153

  • CI Kherson Regional Psychiatric Hospital of Kherson RC

    Kherson,Vil. Stepanivka, 73488

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

    Kyiv, 04080

  • CI Lviv Regional Clinical Psychiatric Hospital

    Lviv, 79021

  • CI Odesa Regional Medical Center of Mental Health

    Odesa, 65006

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

    Poltava, 36006

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

    Ternopil, 46020

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

    Vinnytsia, 21005

Other trials in Ukraine

Russia7 sites

  • Regional Government Institution Kipetsk Regional Psychoneurology Hospital

    Lipetsk, 399083

  • St. Petersburg State Healthcare Institution (SPSHI)

    Saint Petersburg, 190005

  • FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

    Saint Petersburg, 192019

  • SHI Regional Clinical Psychiatry Hospital of St. Sofia

    Saratov, 410060

  • FSBSI "Scientific Research Institute of Mental Health"

    Tomsk, 634014

  • Nizhny Novgorod Regional State Institution of Healthcare

    Velikiy Novgorod, 603155

  • Sverdlov regional Psychiatric Clinical Hospital

    Yekaterinburg, 620030

Other trials in Russia

Bulgaria4 sites

  • MHC - Ruse, EOOD

    Rousse, 7003

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431

  • MHAT-Targovishte, AD

    Targovishte, 7700

  • MHAT 'Sv. Marina', EAD

    Varna, 9003

Other trials in Bulgaria

Philippines4 sites

  • Alexian Brothers Health and Wellness Center

    Daveo City, 8000

  • West Visayas State University Medical Center

    Iloilo City, 5000

  • National Center for Mental Health

    Mandaluyong, 1553

  • Veterans Memorial Medical Center

    Quezon City, 1101

Other trials in Philippines

Colombia3 sites

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla

  • E.S.E. Hospital Mental de Antioquia

    Bello, 0000

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogotá, 00000

Other trials in Colombia

Mexico3 sites

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

    Culiacán, 80020

  • Accelerium S. de R.L. de C.V.

    Monterrey, 64000

  • Instituto de Informacion de Investigacion en Salud Mental

    Monterrey, 64710

Other trials in Mexico

Poland3 sites

  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Torun, 87-100

  • NZOZ Poradnia Zdrowia Psychicznego

    Tyniec Mały, 55-040

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

Other trials in Poland

Puerto Rico3 sites

  • Centro de Investigacion Clinica Psiquiatrica

    Caguas, 00725

  • Centro de Investigacion Clinica Psiquiatrica

    Ponce, 00731

  • INSPIRA Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

Romania3 sites

  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

    Bucharest, 041914

  • Spitalul Clinic de Psihiatrie Socola

    Iași, 700282

  • Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

    Timișoara, 300239

Other trials in Romania

South Korea3 sites

  • Inha University Hospital

    Incheon, 400-711

  • Chonbuk National University Hospital

    Jeonju, 561-712

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

Other trials in South Korea

United Kingdom3 sites

  • Royal Cornhill Hospital

    Aberdeen, Strathclyde, AB25 2ZH

  • Northcroft

    Birmingham, B23 6DW

  • Royal Edinburgh Hospital

    Edinburgh, EH10 5HF

Other trials in United Kingdom

France2 sites

  • CHU Nantes - Hôpital Mère-Enfant

    Nantes, Loire Atlantique, 44093

  • Hôpitaux Pédiatriques de Nice CHU-Lenval

    Nice, 06200

Other trials in France

Hungary2 sites

  • Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

    Budapest, 1021

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, 5700

Other trials in Hungary

Spain2 sites

  • Hospital Sant Joan de Deu

    Barcelona, 08950

  • Hospital Marítimo de Torremolinos

    Torremolinos, Málaga, 29620

Other trials in Spain

Belgium1 site

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

Other trials in Belgium

Malaysia1 site

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

About this study

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

Efficacy and Safety study of Lurasidone in pediatric patients.

Read the 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
Being tested
Lurasidone 40 mg, Lurasidone 80 mg, Placebo 40 or 80 mg
Keywords
schizophrenia, Lurasidone, Latuda
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lurasidone 40 mgDrug

    Also called Latuda

    Lurasidone 40 mg once daily

  • Lurasidone 80 mgDrug

    Also called Latuda

    Lurasidone 80 mg once daily

  • Placebo 40 or 80 mgDrug

    Placebo 40 or 80 mg once daily

Study groups in NCT01911429
Study groupRoleWhat they receive
Lurasidone 40 mgExperimentalLurasidone 40 mg once daily
Receives: Drug: Lurasidone 40 mg
Lurasidone 80 mgExperimentalLurasidone 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
Receives: Drug: Lurasidone 80 mg
PlaceboPlacebo comparatorPlacebo 40 or 80 mg once daily
Receives: Drug: Placebo 40 or 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 6 weeks

Secondary outcomes (8)

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

    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.

    Measured: baseline, week 6

  2. Change From Baseline in PANSS Positive Subscale Scores

    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.

    Measured: baseline, week 6

  3. Change From Baseline in PANSS Positive, Negative Subscale Scores

    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.

    Measured: baseline, week 6

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

    PANSS responder analysis over time: achieving >= 20% reduction from baseline

    Measured: week 6

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

    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.

    Measured: baseline, week 6

  6. Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS)

    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.

    Measured: baseline, week 6

  7. Change From Baseline in PANSS General Psychopathology Subscale Scores

    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.

    Measured: baseline, week 6

  8. Change From Baseline in PANSS Excitability Subscale Scores

    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.

    Measured: baseline, week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01911429
Sponsor's protocol ID
D1050301
Other IDs
2013-001695-38
Status last verified
Mar 2017
First submitted
22 Jul 2013
Last updated
18 Apr 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone 40 mg and Lurasidone 80 mg in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 90 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Ukraine, Russia, Bulgaria, Philippines and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6. (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01911429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Pediatric Schizophrenia Efficacy and Safety Study | AzTrials