title: The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders.
abstract: OBJECTIVE
  Psychotropic medications, including the atypical antipsychotics, have historically been scrutinized for cardiac effects and risk of sudden death. Aripiprazole is an atypical antipsychotic approved for pediatric use in schizophrenia, bipolar I disorder, and autistic disorder. Adult studies have evaluated aripiprazole's effects on electrocardiograms, but no pediatric studies have been published to date.
  
  
  METHODS
  Electrocardiographic data were collected from children and adolescents participating in a 14-week, prospective, open-label study (n=25) of aripiprazole for irritability in pervasive developmental disorder not otherwise specified and Asperger's disorder. A 12-lead electrocardiogram was obtained at the baseline and end point visits. The electrocardiograms were evaluated for abnormal findings, and the PR, QRS, QT(c), and RR intervals were recorded. The QT interval was corrected using Bazett's, United States Food and Drug Administration (FDA) Pharmacology Division, and Fridericia's formulas.
  
  
  RESULTS
  Twenty-four subjects received both baseline and posttreatment electrocardiograms. The mean age was 8.6 years (range 5-17 years). The average final aripiprazole dose was 7.8 mg/day (range 2.5-15 mg/day). There were no significant differences noted with the PR, QRS, RR, and QT(c) intervals after aripiprazole therapy. Also, there was no significant correlation between the dose given and the percent change in the QT(c). No post-treatment QT(c) exceeded 440 ms.
  
  
  CONCLUSIONS
  To our knowledge, this is the first systematic evaluation of the cardiac effects of aripiprazole in children and adolescents. The results are consistent with previously published literature in adults that aripiprazole has no significant cardiac effects and can be deemed a low risk for causing sudden death. It will be important to confirm these findings in a randomized controlled trial.
authors: Section of Pediatric Cardiology, Department of Pediatrics, James Whitcomb Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana 46202-5200, USA.
authors: Jason G
authors: JG
authors: Ho
authors: Randall L
authors: RL
authors: Caldwell
authors: Christopher J
authors: CJ
authors: McDougle
authors: Danielle K
authors: DK
authors: Orsagh-Yentis
authors: Craig A
authors: CA
authors: Erickson
authors: David J
authors: DJ
authors: Posey
authors: Kimberly A
authors: KA
authors: Stigler
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000068180:Aripiprazole; D020817:Asperger Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy* / Q000503:physiopathology; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D008297:Male; D010865:Pilot Projects; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole