Effectiveness and tolerability of long-acting risperidone: A 9-month open-label extension of a 12-week switching study from oral antipsychotics.

ABSTRACT

Objectives. The aim of this non-randomized, single-arm, multi-center, 9-month extension study was to evaluate the maintained efficacy and tolerability of long-acting risperidone injection when we switched to it from previous oral antipsychotics in symptomatically stable patients with schizophrenia or other psychotic disorders. Methods. A total of 98 patients who had completed a previous 12-week acute phase study were included. Efficacy and tolerability were assessed with the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI), Global Assessment of Functioning (GAF), and Extrapyramidal Symptom Rating Scale (ESRS). Results. The remission rate of 77.6% (76/98) at baseline and 57.1% (56/98) at the end of the study. Of patients who were in remission at baseline, 65.8% (50/76) maintained their remission state until the end. The symptom worsening rate was relatively low (11.1%), and there was no aggravation in mean PANSS total and subscale scores. Spontaneous treatment-emergent adverse events (TEAE) were reported by 21 (21.4%) patients, and most commonly reported adverse events were extrapyramidal symptoms (N=6, 6.1%) and insomnia (N=4, 4.1%). Extrapyramidal symptoms were significantly improved. Conclusions. Switching to long-acting risperidone injection from oral antipsychotics was a safe and well-tolerated strategy for maintaining clinical stability in symptomatically stable patients with schizophrenia.