Ziprasidone in adolescents with autism: an open-label pilot study.
BACKGROUND
The antipsychotic drugs are the best-studied agents shown to reduce symptoms in autism, including hyperactivity, aggression, self-abusive behavior, temper tantrums, lability, irritability, social withdrawal, and stereotypical behaviors. However, significant weight gain has been associated with use of many atypical agents. Ziprasidone has been weight neutral in adult populations, but data from adolescents and patients with autism are sparse. However, ziprasidone administration has been associated with increases in the QTc. The purpose of this study was to collect pilot data on the efficacy and safety of ziprasidone in adolescents with autism, focusing on safety issues of weight gain and QTc.


METHODS
Twelve adolescents with autism (mean age 14.5 +/- 1.8 years) were treated in a 6-week open pilot study. Ziprasidone dosage ranged from 20 to 160 mg/day (mean, 98.3 +/- 40.4 mg/day). The primary efficacy measure was the Clinical Global Impressions-Improvement item (CGI-I); other efficacy measures included the Aberrant Behavior Checklist and the Children's Psychiatric Rating Scale.


RESULTS
Based on the CGI-I, 9 of 12 (75%) patients were treatment responders. Ziprasidone was weight neutral, and the QTc increased by a mean of 14.7 msec. Two subjects had acute dystonic reactions. Cholesterol decreased and prolactin remained the same.


CONCLUSIONS
Ziprasidone shows promise as a treatment for adolescents with autism. More definitive trials are needed.
Malone
Richard P
RP
Department of Psychiatry, Drexel University College of Medicine, 4641 Roosevelt Boulevard, Philadelphia, PA 19124, USA. rmalone@drexelmed.edu
Delaney
Mary Anne
MA
Hyman
Susan B
SB
Cater
Jacqueline R
JR
D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000188:drug therapy*; D002648:Child; D002784:Cholesterol / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004421:Dystonia / Q000139:chemically induced; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011388:Prolactin / Q000187:drug effects; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone; D011388:Prolactin; D002784:Cholesterol