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NCT00312494 · ClinicalTrials.gov registry record · Phase 3
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 680
- Enrollment target
NCT00312494: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00312494 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 680 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00312494, 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
- 680 participants
- Enrollment target
Study Summary
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
Primary Outcome
YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \[rate and amount\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS
Interventions
- DRUG Placebo
- DRUG Ziprasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00312494 record still lists
NCT00312494 is an interventional study that assigns participants to a tested intervention. The registered 680 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 (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00312494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00312494 about?
NCT00312494 is a clinical study titled "3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects". 3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
What is the current status of trial NCT00312494?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2006-04. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00312494?
The interventions under investigation include: Placebo (DRUG), Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT00312494?
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 NCT00312494's enrollment target sits among peer trials
680 532nd of 2000 higher than 1,465 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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