Efficacy and Safety Profile of Risperidone Long-acting Injection in Adolescents in a Real-life Setting.

Abstract

ObjectiveRisperidone long-acting injection (RLAI) was shown to be an alternative option in adult patients, but there is not available data in child and adolescents about this medication. The aim of this study is to evaluate the safety and efficiency profile of RLAI in a group of adolescents.MethodsEleven cases with conduct disorder and severe aggressive behaviors were initiated treatment with risperidone oral form. All cases were then shifted to RLAI 25 mg injection in each 15 days due to poor compliance to oral risperidone treatment. Efficiency of treatment included indicators of clinical severity and improvement, which were evaluated by Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I). Safety evaluation was performed by using Extrapyramidal Symptoms Rating Scale, and by monitoring body weight. Follow-up visits were done at the treatment initiation, and 8th, 16th, and 24th weeks of first injection.ResultsStudy included 9 girls, and 2 boys, with a mean age of 14.9±1.0 years. The CGI-S scores decreased from 6.6±0.5 at the beginning to 2.2±1.1 at the last visit (p<0.001), which is a very significant decrease through better clinical level. The CGI-I scores were also improved significantly from 2.4±0.5 to 1.9±0.5 at 24th week (p=0.001). Safety parameters were also showed favorable results, which there was no significant weight gain (p=0.076), and well-tolerated extrapyramidal adverse effects.ConclusionOur results showed that RLAI is an efficient and safe medication option in the treatment of psychiatric disorders and severe behavioral problems in adolescents with low-compliance to oral treatment in our cases.