Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

• Conditions: Adolescent Schizophrenia; MedDRA version: 14.1Level: LLTClassification code 10039629Term: Schizophrenia childhoodSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2007-000577-38-Outside-EU/EEA
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Must be male or female, between 12 and 17 years of age, inclusive. Subject must meet the DSM-IV criteria for schizophrenia for at least one year. Parents or legal guardians must sign an informed consent and subjects must sign an assent. Subjects must be otherwise physically healthy and have no active or clinically significant medical problems. Subjects must weigh >/=29 kg. Female subjects were capable of pregnancy must take appropriate contraceptive measures or agree to abstinence throughout the duration of the study. Subjects must not be a danger to themselves or others.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
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 who meet DSM-IV criteria for a major axis I disorder, mild, moderate, or severe mental retardation, a known or suspected history of substance dependence in the three months preceding screening, or at increased risk for the occurrence of QT prolongation are excluded. Subjects with a known or suspected history of seizure disorder, NMS, TD, IDDM, active malignancy, or a significant or unstable medical illness are excluded. Subjects with a significant abnormality in clinical laboratory tests or ECG are also excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified