Aripiprazole in children and adolescents with tourette's disorder: An open-label safety and tolerability study

Objective: The aim of this study was to conduct a prospective safety and tolerability study of aripiprazole for the treatment of tics in children and adolescents with Tourette's disorder (TD). Method: Eleven subjects (10 males) with TD (age 9-19 years, mean 13.36, standard deviation [SD] 3.33) who did not respond or were unable to tolerate previous tic medication were treated with aripiprazole in an open-label, flexible-dosing study over 10 weeks. Tic severity was rated using the Yale Global Tic Severity Scale (YGTSS) and the Clinical Global Impressions Scale for tics (CGI-Tics) at baseline and at follow-up. Results: The mean (±SD) daily dose for aripiprazole was 4.5 ± 3.0 mg. Mean (±SD) YGTSS Global Severity scores reduced from 61.82 ± 13.49 at baseline to 33.73 ± 15.18 at end point; mean YGTSS total tic scores reduced from 28.18 ± 7.74 at baseline to 16.73 ± 7.54 at end point. Mean (±SD) CGI-Tic severity scores reduced from 4.45 ± 0.52 (moderate-marked) at baseline to 3.18 ± 0.60 (mild) at end point. On the CGI-Tic improvement scale, 10 (91%) subjects achieved 1 ("very much improved") or 2 ("much improved") at end point. Most common adverse effects included appetite increase and weight gain in 5 subjects, mild extrapyramidal effects in 7 subjects, and headaches and tiredness/fatigue in 7 subjects; 1 subject experienced akathisia and muscle cramps. Conclusion: Aripiprazole appears to be a safe and tolerable treatment in children and adolescents with TD that appears to reduce tics; it should be further investigated as a treatment option in controlled trials.