[Risperidone in the treatment of psychotic disorders associated with mental retardation]

The safety and effectiveness of risperidone in patients with a diagnostic of mental retardation and/or psychotic and disturbance disorder was assessed in an open and observational study.

A total of 127 patients with DSM-III-R diagnoses of mental retardation together with psychotic disturbance (psychotic and/or behaviour disturbance) was included in an open label surveillance study. The study objectives were to evaluate safety and efficiency of risperidone in these patients during a six-month period. Risperidone was assessed by the Clinical Global Impression (CGI), schizophrenia subscales of Scale for Evaluating Emotional Disorders in Severely and Profoundly Mentally Retarded Persons (DASH) and Assessment and Information Rating Profile (AIRP), UKU subscale for neurological side effects and spontaneous reports.

Ten patients (7.9%) were excluded from the statistical analysis due to protocol violation. Seventeen patients (14.5%) dropped out. Risperidone was used at a mean dosage of 2.98 (2.37 mg daily. Risperidone produced a significant reduction, vs baseline, in the mean total scores of CGI and DASH-AIRP scales from day 15 onwards. There was a significant reduction in the total UKU subscale for neurological, autonomic side effects scores and psychotic symptoms. Risperidone was generally well tolerated. During the 6 months of study period, 93.2% of the patients did not suffer any adverse event; the resting 7.7% suffered one or more side effects.

In this study, risperidone was a safety and effectiveness treatment in patients with a diagnostic of mental retardation and psychotic and/or disturbance disorder associated.