title: Aripiprazole monotherapy in children and young adolescents with pervasive developmental disorders: a retrospective study.
abstract: 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).
  
  
  METHODS
  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 CGI-Improvement (CGI-I) scales; the Children's Global Assessment 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.
authors.affiliation: IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Calambrone (Pisa), Italy. gabriele.masi@inpe.unipi.it
authors.forename: Gabriele
authors.initials: G
authors.lastname: Masi
authors.forename: Angela
authors.initials: A
authors.lastname: Cosenza
authors.forename: Stefania
authors.initials: S
authors.lastname: Millepiedi
authors.forename: Filippo
authors.initials: F
authors.lastname: Muratori
authors.forename: Cinzia
authors.initials: C
authors.lastname: Pari
authors.forename: Francesco
authors.initials: F
authors.lastname: Salvadori
mesh_terms: D000293:Adolescent; D000367:Age Factors; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001321:Autistic Disorder / Q000188:drug therapy; D016009:Chi-Square Distribution; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy*; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole