Clinical effects and adverse reactions of off-label use of aripiprazole in children and adolescents with developmental disabilities.
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.
Valicenti-McDermott
Maria R
MR
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
Demb
Howard
H
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
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole