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 ± 33.9 mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6–17 years 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 ± 0.4 kg, p = 0.2) or QTc interval (−3.7 ± 4.7, p = 0.5).
Conclusions: 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.