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Ziprasidone in Pediatric Bipolar Disorder: A 6-Week, Open-Label Comparison of Rapid vs. Slow Dose Titration

Kirti Saxena, Annie Walley, Alex Simmons, Paul A. Nakonezny, Cintly Celis-deHoyos, Taryn Mayes, Cheryl L Person and Graham Emslie

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.