A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder

Objective: To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania. Methods: This was an eight-week, open-label, prospective study of ziprasidone monotherapy (57.3±33.9mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6-17years old]. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis. Results: Fourteen of the 21 youth (67%) completed the study. Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (-10.8±8.4, p<0.0001) and 57% had a CGI-I ≤2 at endpoint. Ziprasidone was well tolerated with no statistically significant increase in body weight (0.6±0.4kg, p=0.2) or QTc interval (-3.7±4.7, p=0.5). Coclusion: Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are warranted.