A 2-Year, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5-12 mg/day) in the Treatment of Adolescents (12 to 17 Years of Age) with Schizophrenia
- Conditions
- Adolescents SchizphreniaMedDRA version: 9.1Level: LLTClassification code 10008525Term: Childhood schizophrenia
- Registration Number
- EUCTR2007-000577-38-FI
- Lead Sponsor
- Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
·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
·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:
–heart rate of <50 bpm for subjects between 13 to 17 years of age, inclusive, and heart rate <55 bpm for subjects less than 13 year 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 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
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