Open-Label Study to Evaluate the Safety and Pharmacokinetics of Single-and Multiple-Dose Extended-Release OROS Paliperidone in Pediatric Subjects (>/= 10 to </= 17 Years of Age) with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder - Pediatric Subjects with Schizophrenia, Schizoaffective or Schizophreniform Disorder

Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Registration Number: EUCTR2005-005343-26-FI

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 82

Inclusion Criteria

Subjects may be male or female and must be between 10 and 17 years of age, inclusive (subjects may become 18 during the study but must be 17 years of age on Day 1).

Subjects height and weight must be within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex

Subjects must have a diagnosis of schizophrenia of any subtype (295.10; 295.20; 295.30; 295.60; 295.90), schizoaffective disorder (295.70), or schizophreniform disorder (295.40), according to the DSM-IV-TR.

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

Subjects with an active DSM-IV-TR axis I diagnosis other than schizophrenia, schizoaffective disorder, or schizophreniform disorder

Subjects with a history of DSM-IV-TR diagnosis of substance dependence within 6 months before screening (nicotine and caffeine dependence are not exclusionary)

Subjects who are involuntarily committed to psychiatric hospitalization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the pharmacokinetics of paliperidone after single-dose administration and at steady state following multiple oral administrations of paliperidone ER (using population PK modeling), in children and adolescent subjects (10 to 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder. ;Secondary Objective: To evaluate the safety and tolerability of paliperidone ER in this subject population;Primary end point(s): The hypothesis of the study is that paliperidone ER will be well tolerated in children and adolescent subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and will display the expected PK characteristics in this population.

Secondary Outcome Measures