alexa Ziprasidone in Pediatric Bipolar Disorder: A 6-Week, Open-Label Comparison of Rapid vs. Slow Dose Titration | OMICS International | Abstract
ISSN: 2167-1044

Journal of Depression and Anxiety
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Research Article

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
Tel: 832-822-3750
Fax: 832-825-3747
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.

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.

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