Ziprasidone in Pediatric Bipolar Disorder: A 6-Week, Open-Label Comparison of Rapid vs. Slow Dose Titration
|Kirti Saxena1*, Annie Walley2, Alex Simmons3, Paul A. Nakonezny4, Cintly Celis-deHoyos5, Taryn Mayes6, Cheryl L Person7 and Graham Emslie8|
|1Kirti Saxena- Baylor College of Medicine,USA|
|2Annie Walley- University of Texas Southwestern Medical School,USA|
|3Alex Simmons- University of Texas Southwestern Medical School,USA|
|4Paul Nakonezny- University of Texas Southwestern Medical School,USA|
|5Cintly Celis-deHoyos- Brown University,USA|
|6Taryn Mayes- University of Texas Southwestern Medical School,USA|
|7Cheryl Person- University of Texas Health Science Center at Houston,USA|
|8Graham Emslie- University of Texas Southwestern Medical School,USA|
|*Corresponding Author :||Kirti Saxena, M.D
Associate Professor of Psychiatry
Department of Psychiatry, Division of Child/Adolescent Psychiatry
Baylor College of Medicine, 6701 Fannin St.
Suite 1740, Houston, TX 77030, USA
E-mail: [email protected]
|Received May 10, 2013; Accepted June 20, 2013; Published June 27, 2013|
|Citation: Saxena K, Walley A, Simmons A, Nakonezny PA, Celis-deHoyos C, et al. (2013) Ziprasidone in Pediatric Bipolar Disorder: A 6-Week, Open- Label Comparison of Rapid vs. Slow Dose Titration. J Depress Anxiety 2:130. doi:10.4172/2167-1044.1000130|
|Copyright: © 2013 Saxena K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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.