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NCT00483548 · ClinicalTrials.gov registry record · Phase 3
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 298
- Enrollment target
NCT00483548: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00483548 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 298 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00483548, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 298 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.
Primary Outcome
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MA
Interventions
- DRUG Placebo
- DRUG Ziprasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00483548 record still lists
NCT00483548 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00483548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00483548 about?
NCT00483548 is a clinical study titled "Adjunctive Ziprasidone in the Treatment of Bipolar I Depression". The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of ...
What is the current status of trial NCT00483548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2007-10. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00483548?
The interventions under investigation include: Placebo (DRUG), Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT00483548?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00483548's enrollment target sits among peer trials
298 1162nd of 2000 higher than 838 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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