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Trial record 94 of 3003 for:    Schizophrenia

Pediatric Schizophrenia Efficacy and Safety Study

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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

Tracking Information
First Submitted Date  ICMJE July 22, 2013
First Posted Date  ICMJE July 30, 2013
Results First Submitted Date  ICMJE December 1, 2016
Results First Posted Date  ICMJE March 22, 2017
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
The primary efficacy variable is change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6. [ Time Frame: Baseline to 6 weeks ]
Change History Complete list of historical versions of study NCT01911429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
  • Change from Baseline in Clinical Global Impression severity (CGI-S) scale at Day 4, Weeks 1, 2, 3, 4, 5, and 6 [ Time Frame: 6 weeks ]
  • Change from Baseline in PANSS total score at Day 4, Weeks 1, 2, 3, 4, and 5 [ Time Frame: 5 weeks ]
  • Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Day 4, Weeks 1, 2, 3, 4, 5, and 6 [ Time Frame: 6 weeks ]
  • Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6 [ Time Frame: 6 weeks ]
  • Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6 [ Time Frame: 6 weeks ]
  • Change from Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) at Week 6 [ Time Frame: 6 weeks ]
  • Adverse Events [ Time Frame: 6 weeks ]
  • Vital signs - will consist of supine systolic and diastolic blood pressures, respiration rate, heart rate, and oral body temperature [ Time Frame: 6 weeks ]
  • Weight and Waist circumference [ Time Frame: 6 weeks ]
  • CogState Computerized Cognitive Test Battery [ Time Frame: 6 weeks ]
  • Barnes Akathisia Rating Scale (BARS) [ Time Frame: 6 weeks ]
  • Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 6 weeks ]
  • Simpson-Angus Scale (SAS) [ Time Frame: 6 weeks ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 weeks ]
  • Tanner Staging [ Time Frame: 6 weeks ]
  • Menstrual Cyclicity - At Baseline, female subjects will be given a calendar to mark the beginning and end of each menses. History of menstrual cyclicity and irregularities will be collected at Visit 1. [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Schizophrenia Efficacy and Safety Study
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Lurasidone 40 mg
    Lurasidone 40 mg once daily
    Other Name: Latuda
  • Drug: Lurasidone 80 mg
    Lurasidone 80 mg once daily
    Other Name: Latuda
  • Drug: Placebo 40 or 80 mg
    Placebo 40 or 80 mg once daily
Study Arms  ICMJE
  • Experimental: Lurasidone 40 mg
    Lurasidone 40 mg once daily
    Intervention: Drug: Lurasidone 40 mg
  • 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
    Intervention: Drug: Lurasidone 80 mg
  • Placebo Comparator: Placebo
    Placebo 40 or 80 mg once daily
    Intervention: Drug: Placebo 40 or 80 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
327
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2013)
249
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Colombia,   France,   Hungary,   Korea, Republic of,   Malaysia,   Mexico,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01911429
Other Study ID Numbers  ICMJE D1050301
2013-001695-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lurasidone Medical Director Sunovion
PRS Account Sunovion
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP