Case series: use of ziprasidone for maladaptive symptoms in youths with autism.
OBJECTIVE
To conduct a preliminary evaluation of the safety and effectiveness of ziprasidone in children, adolescents, and young adults with autism.


METHODS
Twelve patients (mean age +/- SD, 11.62 +/- 4.38 years; range, 8-20 years) with DSM-IV-defined autism (n = 9) or pervasive developmental disorder not otherwise specified (n = 3) received open-label treatment with ziprasidone (mean daily dose, 59.23 +/- 34.76 mg; range, 20-120 mg) for at least 6 weeks (mean duration, 14.15 +/- 8.29 weeks; range, 6-30 weeks).


RESULTS
Six (50%) of the 12 patients were considered responders based on a Clinical Global Impression Scale rating of "much improved" or "very much improved." Transient sedation was the most common side effect. No cardiovascular side effects, including chest pain, tachycardia, palpitations, dizziness, or syncope, were observed or reported. The mean change in body weight for the group was -5.83 +/- 12.52 lb (range, -35 to +6 lb). Five patients lost weight, five had no change, one gained weight, and one had no follow-up weight obtained beyond the baseline measurement.


CONCLUSIONS
Ziprasidone appears to have the potential for improving symptoms of aggression, agitation, and irritability in children, adolescents, and young adults with autism. Significant weight gain was not observed in this short-term trial. Double-blind, placebo-controlled studies are needed to substantiate these preliminary findings.
McDougle
Christopher J
CJ
Department of Psychiatry, Indiana University School of Medicine, Indianapolis 46202-4800, USA.
Kem
Deborah L
DL
Posey
David J
DJ
D000293:Adolescent; D000328:Adult; D000374:Aggression / Q000187:drug effects; D001321:Autistic Disorder / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011595:Psychomotor Agitation / Q000188:drug therapy / Q000523:psychology; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*
D010879:Piperazines; D012702:Serotonin Antagonists; D013844:Thiazoles; C092292:ziprasidone