TORONTO — Ziprasidone holds promise as a treatment for childhood bipolar disorder, Dr. Joseph Biederman reported in a poster at the joint annual meeting of the American Academy of Child and Adolescent Psychiatry and the Canadian Academy of Child and Adolescent Psychiatry.
Dr. Biederman of Harvard Medical School, Boston, investigated the drug's effect in an 8-week study of 21 patients aged from 6 to 17 years (mean age 10 years).
All of the children who participated in the study had bipolar disorder. The children were displaying manic, hypomanic, or mixed symptoms, with or without psychoses.
The study participants were not taking any mood stabilizers or any other neuroleptic drugs. At baseline, their mean Young Mania Rating Scale (YMRS) score was 26; their mean IQ was 100.5.
Patients received an initial daily dose of 1 mg/kg ziprasidone, which was titrated upward to 1.5 mg/kg by week 2, and 2 mg/kg by week 3 if tolerated. At the close of the study, the mean daily dose was 56 mg/day.
By the end of week 1, the mean YMRS score had decreased by 8 points. By the end of the study, the mean YMRS score had decreased to 15—a drop of 11 points.
More than half the patients (57%) had a 30% reduction in baseline YMRS scores and were rated as much or very much improved in the Clinical Global Impression scale. One-third of the patients had a YMRS score reduction of 50%.
Comorbid psychiatric symptoms also improved in some patients, Dr. Biederman wrote; 38% had an improvement in depression, 27% improved their attention-deficit hyperactivity disorder symptoms, and 7% of the patients improved their conduct symptoms.
However, he said, only 66% (14) completed the 8-week trial; dropouts were attributable to adverse events (2) and lack of efficacy (5).
The most frequently reported adverse effects experienced by the patients were sedation (46%), headache (38%), and GI problems (34%).
Ziprasidone was not associated with any statistically significant increase in body weight or QTc interval.
The drug has been previously shown safe and effective in adults with bipolar disorder, with limited impact on prolactin levels and weight gain, Dr. Biederman commented.
Dr. Biederman has received grants from Pfizer, which makes the drug. The poster was sponsored by the nonprofit Stanley Medical Research Institute.