Ziprasidone in Pediatric Bipolar Disorder
This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators hypothesize that slower titration of ziprasidone will result in lesser side effects which will assist in medication compliance as measured by patient report and pill count.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ziprasidone in Pediatric Bipolar Disorder: a 6-week, Open-label Comparison of Rapid vs. Slow Dose Titration|
- Young Mania Rating Scale (YMRS) [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.
- Clinical Global Impressions (CGI) Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- SAFTEE (Side Effects Rating Scale) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
- AIMS (Abnormal Involuntary Movement Scale) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
- Children's Depression Rating Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Active Comparator: ziprasidone rapid dose
Rapid Dose Titration Group
Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
Other Name: Geodon
Active Comparator: ziprasidone slow dose
Slow Dose Titration Group
Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
Other Name: Geodon
This study will enroll approximately 60 children and adolescents aged 10-17 years who have been diagnosed with bipolar disorder. Their participation will last about 8 weeks (2 weeks of screening and 6 weeks of medication management) and enrollment will last for two years. After the screening period, all subjects who meet inclusion/exclusion criteria will be randomized to either rapid or slow dose titration of ziprasidone. Subjects in the rapid titration group will reach their maximum dose of study drug over 2 weeks, subjects in the slow titration group over 4 weeks. The study doctor may deviate from the dosing schedule if clinically indicated. The primary data analysis of this pilot study will examine the effect of rapid- versus slow-dose titration of ziprasidone on manic symptoms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622739
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Kirti Saxena, MD||UT Southwestern Medical Center|