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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag S.p.A.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

• Required long-term antipsychotic therapy at the time of recruitment

• Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)

• Patients or their legal representatives provided their written informed consent prior to enrollment in the study

Exclusion Criteria:

• Patients who had received clozapine during the previous 3 months

• Participated in an investigational drug trial in the previous 30 days

• Previously been shown to be either intolerant or non-responsive to risperidone therapy

• Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome

• Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception