A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
Condition: Psychotic Depression; Severe Major Depression With Psychotic Features; Psychosis
MeSH terms: Depression; Depressive Disorder; Psychotic Disorders; Mental Disorders; Depressive Disorder, Major
Intervention: mifepristone; placebo
Intervention description: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days; Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
Intervention MeSH terms: Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 292.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: psychotic depression; major depression with psychotic features; psychosis

Summary:

      Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days
      followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed
      by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in
      patients with a diagnosis of psychotic depression.
    

Eligibility criteria:

        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