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

NCT ID: NCT01888107

Last Updated: 2013-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-04-30

Brief 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.

Detailed 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risperidone Long-acting Injectable (LAI)

Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.

Group Type: EXPERIMENTAL

Risperidone Long-acting Injectable (LAI) 25 mg

Intervention Type: DRUG

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Risperidone LAI 37.5 mg

Intervention Type: DRUG

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Risperidone LAI 50 mg

Intervention Type: DRUG

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Interventions

Risperidone Long-acting Injectable (LAI) 25 mg

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Intervention Type: DRUG

Risperidone LAI 37.5 mg

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Intervention Type: DRUG

Risperidone LAI 50 mg

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag S.p.A., Italy Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag S.p.A.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1372&filename=CR004993_CSR.pdf

Maintenance of clinical response with risperidone long-acting injectable (R-LAI) in subjects with schizophrenia or schizoaffective disorder

Other Identifiers

2004-000830-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR004993

Identifier Type: -

Identifier Source: org_study_id