Aripiprazole monotherapy in children and young adolescents with pervasive developmental disorders: A retrospective study

Gabriele Masi, Angela Cosenza, Stefania Millepiedi, Filippo Muratori, Cinzia Pari, Francesco Salvadori

Research output: Contribution to journalArticlepeer-review


Background: Pervasive developmental disorders (PDDs) are severe psychiatric disorders characterized by impairment in social interactions, in verbal and non-verbal communication, and by restricted and stereotyped patterns of interest and behaviour, with onset in the first 3 years of life. The appropriate use of pharmacotherapy can improve some aberrant symptoms and behaviours and increase the person's response to non-pharmacological interventions. Objective: To describe clinical outcomes, or symptom changes, and adverse effects during naturalistic treatment with aripiprazole monotherapy in children with PDDs and severe behavioural disorders (such as aggression against self and/or others, hostility, hyperactivity, severe impulsiveness). Method: This retrospective naturalistic study included 34 patients (23 males and 11 females, age range 4.5±15 years, mean age 10.2 ± 3.3 years), admitted during 2006±2007, diagnosed according to DSM-IV criteria and followed up for 4-12 months (mean 7.0 ± 3.6 months). Outcome measures were three global measures of clinical and functional impairment and improvement from baseline: the Clinical Global Impression-Severity (CGI-S) and CGIImprovement (CGI-I) scales; the Children'sGlobalAssessment Scale (C-GAS); and the Childhood Autism Rating Scale (CARS), a specific measure of PDD symptoms. Results: The mean baseline CGI-S was 5.7 ± 0.8 (markedly ill/severely ill). The mean final dosage of aripiprazole was 8.1 ± 4.9 mg/day. At the endpoint, 11 patients (32.4%) were 'much improved' or 'very much improved' (CGI-I score of 1 or 2), 12 patients (35.3%) were 'minimally improved' (CGI-I score of 3) and 10 (29.4%) were 'unchanged' or 'worsened' (CGI-I score of 4 or 5). C-GAS and CARS scores significantly improved (p <0.0001, effect sizes 0.59 and 0.62, respectively). Nine patients (26.5%) experienced moderate to severe agitation, which was associated with self-injurious behaviours in five of these patients, and five patients presented with sleep disorders. Twelve patients (35.3%) discontinued medication during the follow-up because of lack of efficacy or adverse effects. Conclusions: In these severely impaired children with PDDs, aripiprazole monotherapy was associated with a significant improvement in maladaptive behaviours in one-third of patients. Agitation and insomnia were the most frequent adverse effects. Further controlled studies in larger samples to explore possible predictors of efficacy are warranted.

Original languageEnglish
Pages (from-to)511-521
Number of pages11
JournalCNS Drugs
Issue number6
Publication statusPublished - 2009

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Psychiatry and Mental health
  • Clinical Neurology


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