Clinical effects and adverse reactions of off-label use of aripiprazole in children and adolescents with developmental disabilities.

OBJECTIVE: The aim of this study was to report on the clinical efficacy and side effects of aripiprazole in treating behavioral symptoms of children with a developmental disability (DDs). DESIGN/METHODS: A retrospective chart review of the first 32 children treated with aripiprazole at an urban clinic for children with DD was conducted. RESULTS: Ages ranged from 5 to 19 years; 9 (28%) were female. Twenty four had diagnoses within the autistic spectrum and 18 had mental retardation (MR). Other disorders included: attention-deficit/hyperactivity disorder/disruptive behavior disorders (n = 13), mood disorders (n = 7), reactive attachment (n = 2), and sleep disorders (n = 2). Target symptoms included aggression, hyperactivity, impulsivity and, self-injurious behaviors. Twenty eight of the children were switched from another antipsychotic. The mean daily aripiprazole starting dose was 7.1 +/- 0.32 mg (0.17 mg/kg/day) and the mean daily maintenance dose was 10.55 +/- 6.9 mg (0.27 mg/kg/day). Aripiprazole had been used for a period between 6 and 15 months. Improvement in target symptoms was found in 56%. When treating a child with MR, the concomitant presence of an autistic spectrum diagnosis predicted a worse outcome. Side effects were reported in 16 (50%), with the most frequent being sleepiness (n = 6). Mean body mass index (BMI) rose from 22.5 to 24.1 (p = 0.003) over the follow up period, with changes in the BMI z scores. These changes were more pronounced in children younger than 12 years. CONCLUSIONS: These results with aripiprazole in this difficult-to-treat population suggest that this medication warrants controlled studies of its effectiveness and safety.