Electrocardiographic changes in children and adolescents treated with ziprasidone: a prospective study.
OBJECTIVE
To assess the electrocardiographic safety profile of low-dose ziprasidone (< or =40 mg/day) among pediatric outpatients treated for up to 6 months.


METHODS
This was a prospective, open-label trial involving 20 subjects with a mean age of 13.2 +/- 3.0 years. Subjects received a mean ziprasidone dose of 30 +/- 13 mg/day and were followed for 4.6 +/- 2.0 months, receiving a median of nine electrocardiograms each (range 2-11; total, 176).


RESULTS
There were statistically significant changes from baseline to peak values in heart rate, PR, and QTc intervals, but not in QRS complex width. The mean QTc prolongation was 28 +/- 26 milliseconds and not related to dose (r = 0.16, p = .07). The peak QTc of three subjects reached or exceeded 450 milliseconds; one subject experienced a 114-millisecond prolongation. There was poor agreement (kappa = 0.25) between automated and manual identification of long QTc intervals (> or =440 milliseconds).


CONCLUSIONS
These preliminary findings, occurring at doses low by current treatment standards, suggest that close electrocardiographic monitoring is warranted when prescribing ziprasidone to children, particularly at higher doses or when combined with other QTc-prolonging agents.
Blair
Jennifer
J
Yale University School of Medicine, New Haven, CT 06520-7900, USA.
Scahill
Lawrence
L
State
Matthew
M
Martin
Andrés
A
D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000150:complications; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced* / Q000175:diagnosis; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000150:complications; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000150:complications / Q000188:drug therapy*; D013844:Thiazoles / Q000009:adverse effects* / Q000627:therapeutic use; D005879:Tourette Syndrome / Q000150:complications
D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone