Adolescents Schizphrenia MedDRA version: 9.1 Level: LLT Classification code 10008525 Term: Childhood schizophrenia
Conditions
Interventions
Product Name: paliperidone ER 1.5mg
Product Code: F071
Pharmaceutical Form: Prolonged-release tablet
Trade Name: Invega
Product Name: paliperidone ER 3.0mg
Product Code: F039
Pharmaceutical Form: Pro
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
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 enrollment) · Subject must give assent to participate before screening procedures begin · 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 not be a danger to themselves or others, and must have family support available to be maintained as outpatients. The K SADS PL diagnostic interview: item a), recurrent thoughts of death; item b), suicidal thoughts; item c), suicide attempts and their seriousness; item d), suicide attempts and their lethality; and item e) self-harming behavior must have a score of £2 for each item. · Weight ³35 Kg Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 A [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) · Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: OBJECTIVES: The primary objective of this study is to evaluate the long-term (6-month) safety and tolerability of paliperidone ER in at least 100 adolescent subjects (12 to 17 years of age, inclusive) with schizophrenia. ;Primary end point(s): PANSS rating from baseline to end of trial;Secondary Objective: Exploratory secondary objectives of this study are to: · Assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores · Assess the global improvement in severity of illness associated with treatment with paliperidone ER as measured by the Clinical Global Impression-Severity (CGI-S) scale · Assess the benefits in psychological, social, and school functioning associated with treatment with paliperidone ER as measured by the Children’s Global Assessment Scale (CGAS) · Assess the changes in multiple domains of cognitive functioning associated with treatment with paliperidone ER as assessed by the modified Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery · Assess the effect on sleep associated with treatment with paliperidone ER as measured by the sleep Visual Analog Scale (VAS) | — |
Countries
Belgium, Bulgaria, Estonia, Finland
Outcome results
None listed