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NCT00208156 · ClinicalTrials.gov registry record · Phase 3

A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

A Phase 3 study, sponsored by Corcept Therapeutics.

Completed
Registry status
Phase 3
Development phase
87
Enrollment target

NCT00208156 is a Phase 3 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 87 participants.

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The verdict

NCT00208156, a Phase 3 study, has completed, sponsored by Corcept Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
87 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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.

Interventions

  • DRUG Mifepristone

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2005-05
Est. Completion 2006-11
Phase Phase 3

Sponsor

Corcept Therapeutics

54 total trials

What the Registry Record Tells You About NCT00208156

The ClinicalTrials.gov registry entry for NCT00208156 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corcept Therapeutics, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Mifepristone is the first listed.

NCT00208156 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00208156 about?

NCT00208156 is a clinical study titled "A United States Extension Study of Corlux for Recurrent 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 NCT00208156?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2005-05. Estimated completion is 2006-11.

What interventions are being tested in trial NCT00208156?

The interventions under investigation include: Mifepristone (DRUG).

Who is sponsoring clinical trial NCT00208156?

This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.