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

Last updated: June 25, 2013
Sponsor: Janssen-Cilag S.p.A.
Overall Status: Completed

Phase

3

Condition

Psychosis

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT01888107
CR004993
2004-000830-35
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Schizophrenia or schizoaffective disorder according to the Diagnostic and StatisticalManual 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 leastone month before the baseline visit (considered stable if there have been noappreciable change in symptoms over the previous month, regardless of the severity oftheir symptoms)

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

Exclusion

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 currentsymptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome

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

Study Design

Total Participants: 347
Study Start date:
January 01, 2005
Estimated Completion Date:
April 30, 2007

Study Description

This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.