Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00280566 · ClinicalTrials.gov registry record · Phase 3
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 584
- Enrollment target
NCT00280566: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00280566 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 584 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00280566, 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
- 584 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
Primary Outcome
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Ra
Interventions
- DRUG Placebo
- DRUG Ziprasidone Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 584 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00280566 record still lists
NCT00280566 is an interventional study that assigns participants to a tested intervention. The registered 584 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 (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00280566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00280566 about?
NCT00280566 is a clinical study titled "Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)". The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
What is the current status of trial NCT00280566?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 584 participants. The study started on 2005-12. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00280566?
The interventions under investigation include: Placebo (DRUG), Ziprasidone Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT00280566?
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 NCT00280566's enrollment target sits among peer trials
584 652nd of 2000 higher than 1,349 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03840083 · 584 participants · NA
Sleep-dependent Learning in Aging
- NCT04984291 · 584 participants · NA
Zimmer Biomet Shoulder Arthroplasty PMCF
- NCT05983757 · 584 participants · NA
Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe
- NCT06569290 · 584 participants · NA
Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia