Schizophrenia MedDRA version: 12.0 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: INVEGA
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: Paliperidone
CAS Number: 144598-75-4
Current Sponsor code: R076477
Other descriptive name: PALIPERIDONE
Concentrat
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?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
Exclusion criteria
Exclusion criteria: ?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] 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of paliperidone PR relative to aripiprazole in the treatment of symptoms of schizophrenia in adolescent subjects (aged 12 to 17 years of age, inclusive) at the Week 8 endpoint as measured by the change from baseline in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) total score.;Secondary Objective: ?Evaluate the maintenance of clinical stability with paliperidone PR compared with aripiprazole at the Week 26 (as measured from Week 8) endpoint based on PANSS total score and Clinical Global Impression Severity (CGI-S) criteria, emergence of clinically significant suicidal or homicidal ideation, and the need for hospitalization due to psychiatric illness. ?Compare the efficacy of paliperidone PR relative to aripiprazole in change from baseline in negative symptoms as measured by the PANSS negative symptom factor score (based on Marder factor) to the Week 8 and Week 26 endpoints. ?Assess the change in the PANSS total score of paliperidone PR compared with aripiprazole from baseline to Week 26 endpoint. ?Assess the change in the global impression of severity of illness associated with the use of paliperidone PR compared with aripiprazole as measured by the CGI-S scale at the Week 8 and Week 26 endpoints. ?Additional secondary objectives listed in protocol.;Primary end point(s): The primary endpoint in the 8-week double blind acute phase will be the change in the PANSS total score from baseline to the last post-randomization assessment up to Week 8. The change from baseline score will be analyzed using an analysis of covariance (ANCOVA) model with treatment group and country as fixed factors and baseline PANSS total score as a covariate. Treatment effect will be estimated based on least-squares (LS) mean of the difference, 95% confidence interval will be presented for the difference in LS mean change. | — |
Countries
Czech Republic, Slovakia, Spain
Outcome results
None listed