A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128479

Enrollment

443

Registered

2005-08-10

Start date

2004-09-30

Completion date

2007-01-31

Last updated

2012-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Psychotic Disorders

Keywords

PMD, Psychotic Depression, Psychosis, Major Depression, Depression, Psychotic Major Depression

Brief 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

DRUGmifepristone

mifepristone 300 mg daily for 7 dats

DRUGmifepristone matched placebo

daily for 7 days

DRUGmifepristone 600 mg

mifepristone 600 mg daily for 7 days

DRUGmifepristone 1200 mg

mifepristone 1200 mg daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Individuals eligible for enrollment into this study are male and female adult patients who: * Are 18 to 75 years of age * Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34) * Are able to provide written informed consent.

Exclusion criteria

Individuals not eligible to be enrolled into the study are those who: * Have a major medical problem * Have previously participated in a CORLUX (C-1073, mifepristone) clinical trial * Have a history of an allergic reaction to CORLUX (C-1073, mifepristone).

Design outcomes

Primary

Measure	Time frame
The change in a measure of psychosis	screen, Days 0, 7, 14, 28, 42, 56

Secondary

Measure	Time frame
The change in a measure of depression	screen, Days 0,7, 14, 28, 42, 56

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026