SAN DIEGO – Intramuscular ziprasidone was well tolerated and effective in a group of children and adolescents who were hospitalized for acute agitation, results from a single-center study showed.
“Some of the typical [antipsychotics cause] extrapyramidal symptoms or acute dystonia, especially in drug-naive patients,” Dr. Drew H. Barzman said in an interview during a poster session at the annual meeting of the American Academy of Child and Adolescent Psychiatry. “We're dealing with a younger population who are more prone to acute dystonia and acute EPS. Ziprasidone is a possible option.”
He and his associates reviewed the medical records of 59 children with a mean age of 14 years who were admitted to the psychiatric unit of Cincinnati Children's Hospital Medical Center for acute agitation between Jan. 1, 2002 and July 11, 2005 and who received intramuscular ziprasidone (Geodon). The study marks an off-label use of the drug. According to prescribing information from the ziprasidone's manufacturer, Pfizer Inc., the safety and efficacy of the drug in pediatric patients has not been established.
The most common primary diagnosis in patients was bipolar disorder (37%), followed by major depressive disorder (20%), mood disorder not otherwise specified (20%), and psychotic disorder (20%).
The researchers used the Behavioral Activity Rating Scale (BARS) to assess clinical response.
Patients received either 10 mg or 20 mg of intramuscular ziprasidone. Sixty-two (81%) of 77 episodes were treated with 20 mg while 15 (19%) were treated with 10 mg, said Dr. Barzman, a child and adolescent psychiatrist at the University of Cincinnati College of Medicine.
The mean BARS score decreased from 6.5 to 3.1. As for adverse events from the drug, 23 patients (30%) reported sleepiness or falling asleep, while 1 reported an increase in seizure frequency, 1 reported dizziness, 1 reported sore muscles and general aches, and 1 reported confusion.
Of the 26 patients who received an electrocardiogram after ziprasidone administration, only 1 patient had a QTc above 500 milliseconds, but that patient did not have a baseline EKG before administration.
Key limitations of the study, Dr. Barzman said, were its retrospective design and lack of a control group.
He disclosed that Pfizer supported the study and that he has received research support and consulting fees from Pfizer.
The study of 59 hospitalized children marks an off-label use of intramuscular ziprasidone. DR. BARZMAN