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NCT00490542 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
A Phase 2 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT00490542: Completed Phase 2 study, sponsored by Tufts Medical Center.
NCT00490542 is a Phase 2 study that has completed, run by Tufts Medical Center. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490542, a Phase 2 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued that mixed states were the most common episodes in manic-depressive illness. A mixed state is defined as a person who is experiencing symptoms of both depression and mania. Currently, a person must have depression plus 3 or more manic symptoms for the episode to be diagnosed mixed. Using this narrow view, less than 10% of episodes in patients with bipolar disorder would meet criteria for a mixed episode. A broader view requires that the person have at least 2 manic symptoms. Using this broader view, data suggest that about 50% of episodes in bipolar disorder would be diagnosable as mixed states. Studies suggest that the majority of persons with a depressive mixed state have bipolar disorder type II. Many people who have a mixed state will also have major depression. Even with such high potential rates of mixed episodes in both bipolar disorder and major depression, there have been few studies addressing the issue. The purpose of this study is to look at how effective Geodon is in treating the depressive mixed state in people with bipolar or major depression. This will be the first clinical trial that is both double-blind and randomized.
Primary Outcome
Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.
Interventions
- DRUG placebo
- DRUG ziprasidone (Geodon)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00490542 record still lists
NCT00490542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00490542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490542 about?
NCT00490542 is a clinical study titled "Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State". Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued that mixed states were the most common episodes in manic-depressive illness. A mixed state is defined as a person who is experiencing symptoms of both depression and mania. Currently, a person must have de...
What is the current status of trial NCT00490542?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2006-12. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00490542?
The interventions under investigation include: placebo (DRUG), ziprasidone (Geodon) (DRUG).
Who is sponsoring clinical trial NCT00490542?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00490542's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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