Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International, Double-Blind, Placebo-Controlled, Study of the Efficacy and Safety of CORLUX™ (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Psychotic Major Depression (PMD)
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).


Options:
A: Inclusion Criteria:

* Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff
* Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
* Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
* Have not been taking excluded medication for at least 7 days prior to randomization
* Have a negative pregnancy test
* If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) to utilize two medically acceptable methods of contraception, one of which is a barrier method, throughout the entire study period and for 3 months after the study is completed

Exclusion Criteria:

* Have any primary psychiatric diagnosis other than psychotic depression.
* Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.
* Have undergone electroconvulsive therapy within 3 months prior to randomization
* Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
* Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
* Are female and are pregnant or lactating
* Are currently taking excluded medications
* Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen
* Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening
* Are in the opinion of the investigator at immediate risk of suicide, or at risk of harming others
* Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization
* Have previously participated in a clinical trial of mifepristone
* Have a history of an allergic reaction to mifepristone
* Are in the investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason
* Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the investigator or Corcept Therapeutics
B: Inclusion Criteria:

* Major depressive disorder, single or recurrent, with psychotic features

Exclusion Criteria:

* History of substance abuse or dependence within the 3 months prior to enrollment
* Acute or unstable medical illness
* Diagnosis of schizophrenia or other psychotic disorders
* Pregnant
* Intolerance to SSRIs or olanzapine
C: Inclusion Criteria:

* Are 18 to 75 years of age
* Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM IV\] 296.24 or 296.34)
* Are able to provide written informed consent.

Exclusion Criteria:

* 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).
D: 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).

Answer: C