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NCT00622739 · ClinicalTrials.gov registry record · Phase 4
Ziprasidone in Pediatric Bipolar Disorder
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT00622739: Completed Phase 4 study, sponsored by Baylor College of Medicine.
NCT00622739 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00622739, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Ziprasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
What the finished NCT00622739 record still lists
NCT00622739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Ziprasidone is the first listed.
NCT00622739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00622739 about?
NCT00622739 is a clinical study titled "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 ziprasi...
What is the current status of trial NCT00622739?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2007-02. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00622739?
The interventions under investigation include: Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT00622739?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00622739's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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