Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study.
OBJECTIVE
The aim of this study was to determine the effectiveness and tolerability of aripiprazole for irritability in pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder.


METHODS
This is a 14-week, prospective, open-label investigation of aripiprazole in 25 children and adolescents diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I).


RESULTS
Twenty-five subjects, ages 5-17 years (mean 8.6 years) received a mean final aripiprazole dosage of 7.8 mg/day (range 2.5-15 mg/day). Full-scale intelligence quotient (IQ) scores ranged from 48 to 122 (mean 84). Twenty-two (88%) of 25 subjects were responders in regard to interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-I of 1 or 2 (very much or much improved) and a 25% or greater improvement on the ABC-I. The final mean CGI-I was 1.6 (p <or= 0.0001). ABC-I scores ranged from 18 to 43 (mean 29) at baseline, whereas scores at week 14 ranged from 0 to 27 (mean 8.1) (p <or= 0.001). Aripiprazole was well tolerated. Mild extrapyramidal symptoms (EPS) were reported in 9 subjects. Age- and sex-normed body mass index (BMI) increased from a mean value of 20.3 at baseline to 21.1 at end point (p <or= 0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point (p <or= 0.0001). No subject exited the study due to a drug-related adverse event.


CONCLUSIONS
These preliminary data suggest that aripiprazole may be effective and well tolerated for severe irritability in pediatric patients with PDD-NOS or Asperger's disorder. Larger-scale placebo-controlled studies are needed to elucidate the efficacy and tolerability of aripiprazole in this understudied population.
Stigler
Kimberly A
KA
Department of Psychiatry, Section of Child & Adolescent Psychiatry, Indiana University School of Medicine and Christian Sarkine Autism Treatment Center, James Whitcomb Riley Hospital for Children, Indianapolis, Indiana 46202-5200, USA. kstigler@iupui.edu
Diener
Jonathan T
JT
Kohn
Arlene E
AE
Li
Lang
L
Erickson
Craig A
CA
Posey
David J
DJ
McDougle
Christopher J
CJ
D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D020817:Asperger Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D015992:Body Mass Index; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy* / Q000503:physiopathology; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D008297:Male; D010865:Pilot Projects; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011388:Prolactin / Q000187:drug effects / Q000378:metabolism; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D011388:Prolactin