title: Clinical effects and adverse reactions of off-label use of aripiprazole in children and adolescents with developmental disabilities.
abstract: OBJECTIVE
  The aim of this study was to report on the clinical efficacy and side effects of aripiprazole in treating behavioral symptoms of children with a developmental disability (DDs).
  
  
  METHODS
  A retrospective chart review of the first 32 children treated with aripiprazole at an urban clinic for children with DD was conducted.
  
  
  RESULTS
  Ages ranged from 5 to 19 years; 9 (28%) were female. Twenty four had diagnoses within the autistic spectrum and 18 had mental retardation (MR). Other disorders included: attention-deficit/hyperactivity disorder/disruptive behavior disorders (n = 13), mood disorders (n = 7), reactive attachment (n = 2), and sleep disorders (n = 2). Target symptoms included aggression, hyperactivity, impulsivity and, self-injurious behaviors. Twenty eight of the children were switched from another antipsychotic. The mean daily aripiprazole starting dose was 7.1 +/- 0.32 mg (0.17 mg/kg/day) and the mean daily maintenance dose was 10.55 +/- 6.9 mg (0.27 mg/kg/day). Aripiprazole had been used for a period between 6 and 15 months. Improvement in target symptoms was found in 56%. When treating a child with MR, the concomitant presence of an autistic spectrum diagnosis predicted a worse outcome. Side effects were reported in 16 (50%), with the most frequent being sleepiness (n = 6). Mean body mass index (BMI) rose from 22.5 to 24.1 (p = 0.003) over the follow up period, with changes in the BMI z scores. These changes were more pronounced in children younger than 12 years.
  
  
  CONCLUSIONS
  These results with aripiprazole in this difficult-to-treat population suggest that this medication warrants controlled studies of its effectiveness and safety.
authors.affiliation: Children's Evaluation and Rehabilitation Center, R.F. Kennedy Center of Excellence in Developmental Disabilities, Albert Einstein College of Medicine, Bronx, New York, USA. rvalicenti@hotmail.com
authors.forename: Maria R
authors.initials: MR
authors.lastname: Valicenti-McDermott
authors.forename: Howard
authors.initials: H
authors.lastname: Demb
mesh_terms: D000293:Adolescent; D000374:Aggression / Q000187:drug effects; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy; D001321:Autistic Disorder / Q000175:diagnosis / Q000188:drug therapy*; D015992:Body Mass Index; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy*; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007175:Impulsive Behavior / Q000175:diagnosis / Q000188:drug therapy; D008607:Intellectual Disability / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D019964:Mood Disorders / Q000175:diagnosis / Q000188:drug therapy; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D019962:Reactive Attachment Disorder / Q000175:diagnosis / Q000188:drug therapy; D016728:Self-Injurious Behavior / Q000175:diagnosis / Q000188:drug therapy; D012893:Sleep Wake Disorders / Q000175:diagnosis / Q000188:drug therapy
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole