Estudio multicéntrico, aleatorizado, doble ciego, controlado, de dosis flexibles y grupos paralelos para evaluar la eficacia y seguridad de paliperidona de liberación prolongada en el tratamiento de los síntomas de la esquizofrenia en sujetos adolescentes de 12 a 17 años de edad.
- Conditions
- SchizophreniaMedDRA version: 12.0Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2009-014811-11-ES
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 228
?Male or female between 12 and 17 years of age, inclusive. Subject may become 18 years of age during the study but should be 17 years of age at the time of signing the informed consent.
?Subjects must currently meet the DSM-IV criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) and have experienced symptoms of the illness for at least one year. The K-SADS-PL questionnaire will be used to establish the diagnosis (including all supplements). Subjects should have had at least one treatment (>6 weeks of treatment at a therapeutic dose) with an antipsychotic before participation in this study.
?Subject must give assent to participate before screening procedures begin. In countries where subjects aged 12-17 years inclusive can give consent, the subject must sign the informed consent document (per local laws).
?Parent(s) or the legal guardian(s) of the subject must sign an informed consent document indicating that they understand the purpose of and the procedures required for the study and give permission for their child?s participation in the study before screening procedures begin
?Subjects must have a PANSS score between 60 and 120 inclusive at screening (and whose physician believes that the subject is not receiving optimal clinical benefit or is experiencing a problem with safety or tolerability of their current anti-psychotic medication)
?Subjects must be otherwise physically healthy on the basis of a physical examination, medical history, ECG, and the results of clinical laboratory tests carried out within 21 days before baseline.
?Female subjects must either:
?be incapable of pregnancy because of hysterectomy or tubal ligation.
?if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier methods) for at least 1 month before study entry and agree to continue the use of one of these contraception methods for the duration of the study.
?if sexually abstinent and capable of pregnancy, agree to continue abstinence or to use an acceptable method of birth control (either hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier method) should sexual activity commence.
?To participate in the optional pharmacogenomic component of this study, subjects (or their legally-acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
?Subjects must not be a danger to themselves or others, and must have family support available to be maintained as outpatients. The Columbia Suicide Severity Rating Scale, Baseline and Since Last Visit Forms will be used to assess suicidal ideation, intensity, and behavior at screening and baseline visits respectively. Subjects must answer no to items 1 and 2 in the C-SSRS Since Last Visit Version administered at baseline in order to be enrolled in the study.
?Weight greater than or equal to 29 Kg
?A responsible adult must be available to accompany the subject to the investigational site at each visit, to provide reliable information for all study related evaluations, and to accurately and reliably dispense the study drug as directed
?Subjects must agree to be hospitalized at any t
?Subjects who, at screening, meet the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed, as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator?s judgment do not require medications (See Section 8, Concomitant Therapy)
?Subjects with mild, moderate, or severe mental retardation (i.e., documented intelligence quotient [IQ] <70), established by previous IQ testing or history
?Subjects with a known or suspected history of substance dependence (including alcohol, but excluding nicotine and caffeine) according to the DSM-IV criteria in the 3 months preceding screening.
?History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval, including:
?At screening and baseline, a supine measured heart rate of <50 bpm for subjects between 13 to 17 years of age, inclusive, and heart rate <55 bpm for subjects 12 years of age.
?demonstration of repeated prolonged QTc Fridericia interval >450 msec, as measured on more than one ECG (either during screening, or from a previous medical record).
?the following cardiac conditions: sick sinus syndrome, complete AV block, congestive heart failure, polymorphic ventricular tachycardia
?clinically relevant hypocalcemia, hypokalemia, or hypomagnesemia
?Concomitant use of drugs that prolong the QTc interval (including Class I [e.g., quinidine, procainamide] or Class III [e.g., amiodarone, sotalol] antiarrhythmic medications); presence of congenital prolongation of the QT interval (Romano-Ward Syndrome, Jervell, and Lange-Nielsen syndrome)
?Subjects with a known or suspected history of seizure disorder, neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
?Subjects who have received clozapine in the 2 months before the baseline visit.
?Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
?History of severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or an inability to swallow oral study drug with the aid of water
?Subjects who, in the opinion of the investigator, should not discontinue or participate in washout of prohibited concomitant psychotropic medications (Section 8, Concomitant Therapy)
?Subjects who have received electroconvulsive therapy in the 3 months preceding baseline
?Subjects who, despite washout, continue to use any prohibited concomitant medication, substance of abuse, or alcohol within 5 half-lives (up to a maximum of 5 days) before baseline, as evidenced by history or as suggested by a positive urine drug screen at baseline
?Subjects who have received a depot injectable antipsychotic within 2 treatment cycles before the screening visit
?Clinically significant abnormalities in medical history, physical examination, ECG or biochemistry, hematology, or urinalysis results. Evidence of clinically significant hepatic disease [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal] at screening
?Known or suspected hypersensitivity or intolerance to rispe
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method