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28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

NCT00946985 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2012-09-10

Study results available
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Summary

The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Conditions

Interventions

DRUG

paliperidone palmitate

50, 75, 100, or 150 mg eq. monthly injection for 2 years

DRUG

oral risperidone

2, 4, 6, or 8 mg tabs once daily for two years

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial · Ortho-McNeil Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • India
  • Malaysia
  • 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 NCT00946985 on ClinicalTrials.gov