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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005343-26-FI

Enrollment

Registered

2006-02-03

Start date

2006-03-17

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Interventions

Product Name: Paliperidone OROS 1mg ER system F053 Product Code: R076477 Pharmaceutical Form: Tablet INN or Proposed INN: Paliperidone Current Sponsor code: R076477 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026