MedTrace Logo

An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder

NCT00992407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-03-11

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).

Conditions

Interventions

DRUG

Risperidone long acting injectables

Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection.

DRUG

Risperidone tablets

Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd. Clinical Trial · Janssen Korea, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • South Korea

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 NCT00992407 on ClinicalTrials.gov