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Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

NCT01726335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-04-29

Study results available
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Summary

The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Conditions

Interventions

DRUG

Risperidone prolonged release

Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd. Clinical trial · Janssen-Cilag Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Brazil

Study Locations

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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 NCT01726335 on ClinicalTrials.gov