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

NCT00488319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-02-10

Study results available
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Summary

The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.

Conditions

  • Schizophrenia
  • Schizophrenic Disorders
  • Psychotic Disorders
  • Dementia Praecox

Interventions

DRUG

Paliperidone ER

1.5 to 12 mg tablet once daily for 6 months

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Belgium
  • Bulgaria
  • Estonia
  • Finland
  • India
  • Poland
  • Romania
  • Russia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488319 on ClinicalTrials.gov