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NCT00128479 · ClinicalTrials.gov registry record · Phase 3
A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
A Phase 3 study, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 443
- Enrollment target
NCT00128479: Completed Phase 3 study, sponsored by Corcept Therapeutics.
NCT00128479 is a Phase 3 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 443 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00128479, a Phase 3 study, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 443 participants
- Enrollment target
Study Summary
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
Interventions
- DRUG mifepristone
- DRUG mifepristone matched placebo
- DRUG mifepristone 600 mg
- DRUG mifepristone 1200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00128479 record still lists
NCT00128479 is an interventional study that assigns participants to a tested intervention. The registered 443 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 (43% lower).
The record links to 0 conditions, and to 4 interventions - of which mifepristone is the first listed.
NCT00128479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00128479 about?
NCT00128479 is a clinical study titled "A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression". Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic majo...
What is the current status of trial NCT00128479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 443 participants. The study started on 2004-09. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00128479?
The interventions under investigation include: mifepristone (DRUG), mifepristone matched placebo (DRUG), mifepristone 600 mg (DRUG), mifepristone 1200 mg (DRUG).
Who is sponsoring clinical trial NCT00128479?
This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00128479's enrollment target sits among peer trials
443 866th of 2000 higher than 1,134 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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