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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Major Depressive Disorder, Psychotic Disorders

Intervention / Treatment
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* Drug: mifepristone
* Drug: mifepristone matched placebo
* Drug: mifepristone 600 mg
* Drug: mifepristone 1200 mg


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mifepristone 300 mg<br> | Drug: mifepristone<br>* mifepristone 300 mg daily for 7 dats<br>|
| Placebo Comparator: placebo<br> | Drug: mifepristone matched placebo<br>* daily for 7 days<br>|
| Experimental: mifepristone 600 mg<br> | Drug: mifepristone 600 mg<br>* mifepristone 600 mg daily for 7 days<br>|
| Experimental: mifepristone 1200 mg<br> | Drug: mifepristone 1200 mg<br>* mifepristone 1200 mg daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in a measure of psychosis |  | screen, Days 0, 7, 14, 28, 42, 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in a measure of depression |  | screen, Days 0,7, 14, 28, 42, 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMD, Psychotic Depression, Psychosis, Major Depression, Depression, Psychotic Major Depression