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

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Janssen

Status and phase

Completed
Phase 3

Conditions

Schizophrenia
Schizoaffective Disorder

Treatments

Drug: Risperidone LAI 50 mg
Drug: Risperidone Long-acting Injectable (LAI) 25 mg
Drug: Risperidone LAI 37.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01888107
2004-000830-35 (EudraCT Number)
CR004993

Details and patient eligibility

About

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.

Full 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.

Enrollment

347 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

347 participants in 1 patient group

Risperidone Long-acting Injectable (LAI)
Experimental group
Description:
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
Treatment:
Drug: Risperidone LAI 37.5 mg
Drug: Risperidone Long-acting Injectable (LAI) 25 mg
Drug: Risperidone LAI 50 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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