At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ziprasidone in Pediatric Bipolar Disorder: a 6-week, Open-label Comparison of Rapid vs. Slow Dose Titration
In Brief
A Phase 4 clinical trial evaluating Ziprasidone for Bipolar Disorder. Completed, enrolled 28 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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.
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.