Abstract
Objective: This open- label clinical trial evaluated the dosing, safety, and effectiveness of rapid vs. slow titration of ziprasidone in pediatric bipolar disorder over a period of 6 weeks. Methods: Study participants (aged 10-17 years) were diagnosed with bipolar disorder using standardized diagnostic instruments. Additionally, standardized rating scales were used to assess changes in mood, adverse effects, and overall functioning. Twenty-eight participants were randomly assigned to either the rapid- or slow-dose titration of ziprasidone. Linear mixed model analyses of repeated measures—adjusting for the age and respective baseline clinical score— were used to evaluate the main effects and the 2-way interaction effect (incorporating titration group and time). Cox Proportional Hazards Regression, adjusting for age, compared the time-to-treatment response for the rapid- vs. the slow-dose titration of ziprasidone. Treatment response was defined as ≥ 50% reduction from baseline on the Young Mania Rating Scale total scores for at least two sustained periods. Results: Irrespective of titration group assignment, mean YMRS total scores decreased significantly across the 6 weeks of treatment for the combined groups (p=.008). The median time to response was 2 weeks for the rapid titration group and 3 weeks for the slow group, but the two survival curves of treatment response did not differ significantly between the two titration groups (p=0.92). Overall, ziprasidone was tolerated well by the study participants in both groups (slow and rapid titration). Conclusions: No significant difference emerged between the rapid- and slow-titration groups over the 6 weeks of ziprasidone treatment on severity of manic symptoms or time-to-response. There was a reduction in manic symptoms in both the rapid and slow titration groups over the 6 week period. A much larger sample is required to test for meaningful differences between the two titration groups, in regards to improving clinical symptoms and minimizing adverse effects from ziprasidone.
Highlights
Bipolar disorder is a serious, chronic illness that significantly impacts the quality of life of an individual
Atypical antipsychotics have been shown to be effective in treating bipolar disorder in youth [2]
Ziprasidone is often favored over other atypicals, because it lacks the association with these adverse effects [3,4]
Summary
Bipolar disorder is a serious, chronic illness that significantly impacts the quality of life of an individual. This disorder has onset in childhood and adolescence [1], which makes it even more important to adequately treat this illness in youth. Atypical antipsychotics have been shown to be effective in treating bipolar disorder in youth [2]. Many atypicals are known to cause significant weight gain, obesity, diabetes mellitus, and hyperlipidemia. The adverse effect profile of ziprasidone appears to be slightly superior to other atypical antipsychotics ( with respect to weight gain and metabolic parameters), appropriate dosing strategies, safety parameters, and efficacy of ziprasidone continue to need to be established for pediatric bipolar youth
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