An open-label study of the efficacy and tolerability of aripiprazole for children and adolescents with tic disorders

Objectives: This study aimed to investigate the efficacy and tolerability of aripiprazole, an atypical antipsychotic with dual agonist and antagonist actions toward dopaminergic imbalance and partial serotonin-2A receptor antagonism, for treating children and adolescents with tic disorders. Method: Twenty-four outpatients aged 7 to 18 years with DSM-IV-diagnosed tic disorders were treated with aripiprazole using an open-label, flexible dosing schedule for 8 weeks from January 2005 to August 2006. The Korean versions of the Yale Global Tic Severity Scale (YGTSS), the Clinical Global Impressions-Improvement scale (CGI-I), and the CGI-Severity of Illness scale (CGI-S) scores were used to measure the drug efficacy. Side effects were assessed using an adverse effect checklist, the Extrapyramidal Symptom Rating Scale, height and weight measurements, laboratory tests, and electrocardiograms. Results: Aripiprazole was prematurely discontinued in 6 (25%) of the 24 subjects due to intolerable adverse effects. After a mean of 9.8 ± 4.8 mg/day of aripiprazole for 8 weeks, there was a 52.8% reduction in the mean YGTSS Total Tic scores (from 26.7 ± 5.5 to 12.6 ± 7.6, p < .001). Nineteen patients (79.2%) showed either much improved or very much improved status according to the CGI-I. The CGI-S score was also reduced (from 5.5 ± 0.5 to 3.0 ± 1.4, p < .001). The initial dose of 5 mg/day aripiprazole for 2 weeks was also found to reduce tic symptoms significantly (Total Tic scores decreased from 26.7 ± 5.5 to 17.9 ± 8.7, p < .001). Fourteen subjects (58.3%) experienced unwanted side effects, the most common being hypersomnia (37.5%), nausea (20.8%), and headache (16.6%). Conclusion: This open-label study suggests that aripiprazole is an efficacious and safe treatment for children and adolescents with tic disorders.