drugset / Trial / NCT01888107

Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder

NCT01888107

Phase 3 Completed 347 enrolled Janssen-Cilag S.p.A.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.

Timeline

Start
2005-01
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 25 mg Intramuscular
Subject Risperidone Other / unclassified 37.5 mg Intramuscular
Subject Risperidone Other / unclassified 50 mg Intramuscular