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Objectives: To describe efficacy and tolerability of aripiprazole monotherapy in children and young adolescents with PDD and severe behavioral disorders.
Methods: 25 patients (17 males and 8 females, age range 4.5 to 15 years, mean age 9.1 ± 3.1 years), enrolled during 2006-2007, diagnosed as PDD according to DSM IV criteria, and followed-up for 3-12 months (mean 6.7 ± 3.7 months) are included. All youths were treated with aripiprazole monotherapy.Outcome measures: CARS, Clinical Global Impression–Improvement (CGI-I) and Children Global Assessment Scale (C-GAS).
Results: Mean CGI Severity Score: 5.84 ± 0.8. Mean dose: 6.7 ± 4.5 mg/day (range 1.25 – 15 mg/day). After the treatment the CARS improved from 42.7 ± 5.3 to 39.4 ± 5.8 (t=4.8, df=24, p=.000). The improvement of the score was only 7.7%, and the effect size was 0.6. The mean CARS score improved from 26.0 ± 6.0 to 29.7 ± 8.5 (t=-3.8, df=24, p=.000), but the improvement was only 14.2%, and the effect size was 0.51. According to the CGI-Improvement Score, only five patients resulted Much or Very Much improved, while 11 patients resulted minimally improved, 6 patients resulted unchanged, and 3 worsened. Fourteen patients experienced agitation during the treatment, in four patients associated with self-injurious behaviors, in five patients associated with insomnia. One patients presented mild extrapyramidal symptoms. Nine patients discontinued the medication during the follow-up, due to side effects and/or lack of efficacy.
Conclusions: In this sample of very severely impaired children and adolescents with PDD, aripiprazole monotherapy resulted only modestly effective for maladaptive behaviors. Behavioral activation and insomnia were the most frequent side effects. Further controlled studies in this age group are warranted.