MedTrace Logo

Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

NCT01362439 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2013-06-05

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Conditions

Interventions

DRUG

Paliperidone ER

Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.

Sponsors & Collaborators

  • Janssen-Cilag S.p.A.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag S.p.A. Italy Clinical Trial · Janssen-Cilag S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31
Completion
2010-03-31

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 NCT01362439 on ClinicalTrials.gov