P03-45 - Psychosocial Functioning of Schizophrenic Patients in Post-Acute Treatment with Long-Acting Injectable Risperidone in Ambulatory Care

Abstract

Introduction

Improvement of social and occupational functioning is a major goal in the treatment of schizophrenic patients and therefore may improve reintegration of patients and their ability to lead an independent life.

Methods

Non-interventional, 52-week study (RIS-SCH-4091) in schizophrenic patients after treatment of exacerbation or first manifestation of schizophrenia (ICD-10 F20.x; duration of disease ≤10 years) with long-acting injectable risperidone (RLAI) in monotherapy. Presented here is the assessment of the treatment based on the Clinical Global Impression (CGI), the Global Assessment of Functioning (GAF), and skills assessing the ability of patients for reintegration as quantified by the short version of the International Classification of Functioning, Disability and Health for Mental Disorders (Mini ICF-APP).

Results

Interim-analysis after 12 months of 75 patients (ITT, m 64%; 32.7±9.1 years; N=88 safety set). Duration of observation was 278.8±119.3 days. GAF total scores improved significantly (24.4±23.7); 76.0% of the patients improved in CGI-C. Mini-ICF-APP total scores improved significantly from 1.96±0.68 to 1.18±0.94 at final observation. All Mini-ICF-APP sub-items improved significantly, particularly within: participation in public roles, non-occupational activities, self maintenance, competency, flexibility, family relations. 119 adverse events (AEs; 28 serious AEs) were reported in 47 patients. Most common AEs at least possibly related to RLAI were lack of effectiveness 8.0%, weight increase 8.0%, psychotic disorder 5.7%, anxiety 3.4%, EPS 3.4%.

Conclusions

Results indicate that treatment with RLAI may improve global functioning of patients by reducing typical disorder of functioning, capacity and participation. Treatment with RLAI may help patients to reintegrate into social and occupational environments.