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-BE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-01
• Last Update Posted: 7 October 2014

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