Objectives: 1. Assess the evolution of disability and quality of life in schizophrenic patients treated with risperidone and who had received depot neuroleptics; 2. Evaluate risperidone efficiency; 3. Evaluate safety of this drug.
Method: Post-marketing multicentric observational (8 months) surveillance study was carried out.
Patients: 109 schizophrenic patients (ICD-10 criteria).
Assessments: baseline and months 2, 4 and 8.
Instruments: SF-36, WHO/DDS-S, BPRS and CGI. Safety was evaluated by the UKU subscale for neurological side effects and spontaneous reports.
Results: statistically significant improvement of the mean scores of BPRS, CGI, WHO/DDS-S and SF-36 at 2, 4 and 8 months. There was a significant reduction in the total UKU subscale for neurological side effects scores from visit 1 (month 2) onwards. Risperidone was generally well tolerated by the study patients. From a total of 104 patients included, only 4 (3.8%) discontinued treatment due to adverse reactions. During the 8 months of study period, 87.6% of the patients did not suffer any adverse event; the resting 12.4 suffered one or more side effects. The most frequently reported adverse events according spontaneous reports were: anxiety and restlessness (n= 4; 3.8%), weight increase (n= 4; 3.8%), sexual disturbances (n= 4; 3.8%) and amenorrhea (n= 2; 1.9%) among others.
Conclusion: the long-term treatment with risperidone has improved the disability and quality of life levels of a large group of schizophrenic patients previously treated with depot neuroleptics.