Major goals in the treatment of schizophrenic out-patients are the reduction and stabilization of psychopathological symptoms, the reduction of relapses and a lasting improvement of the quality of life.

Non-interventional, 52-week study (RIS-SCH-4091) in schizophrenic patients after treatment of exacerbation or first episode of schizophrenia (ICD-10 F20.x) with monotherapy of long-acting injectable risperidone (RLAI).

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. Median start and end dose of RLAI was 37.5 mg/2 weeks. More than 80% of RLAI patients showed 75-100% compliance; 63% improved compliance compared to previous treatment. Improvement from baseline to endpoint was significant (p< 0.0001) for total PANSS (31.4±30.0), SF-12 physical (7.6±11.6) and mental health scores (13.4±12.5) and total SWN-K scores (20.7±23.5). Most patients had no relapse (89%) and no hospitalizations (92%) due to underlying psychosis during the observation period under RLAI compared to 59% with at least one hospitalization within the 12 months prior to this study. Mean relapse free time was 208.6±5.1 days. 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%.

The results indicate that RLAI has good tolerability and good clinical effectiveness in the therapy of schizophrenic out-patients. High compliance, low hospitalization and low relapse rates under RLAI may help patients achieve stable remission and to master daily life.