drugset / Trial / NCT00622739
Ziprasidone in Pediatric Bipolar Disorder
Phase 4
Completed
28 enrolled
Baylor College of Medicine
Children's Medical Center Dallas · collabPfizer · collabStanley Medical Research Institute · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-02
- Primary completion
- 2009-09
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ziprasidone | Small molecule | 160 mg | — |