NCT00774085

An Observational Study to Assess Treatment & Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone

Electronic Schizophrenia Treatment Adherence Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 408 (actual)
• Sponsor: Janssen Cilag N.V./S.A. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.

Detailed description

This is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. This is one-country arm of a multinational study. This study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. Usage of risperidone according to label was recommended during the study. The planned recruitment period will be 6 months. Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. Total duration of prospective observation for each patient with a complete follow-up will be 24 months. Data collection during the follow up period will be scheduled every 3 months ± 2 weeks. In addition, this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. Also, this data will provide documentation on switch from oral to parenteral treatment. Data will be pooled from different physicians and/or countries. The objectives of this study are: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
OTHER	No intervention was given	Participants included patients treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-10-17
• Last updated: 2012-04-27