Conditions: Psychotic Depression Severe Major Depression With Psychotic Features Psychosis
Keywords: psychotic depression major depression with psychotic features psychosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 292
Healthy volunteers: no

Brief 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.

Detailed description:
Up to 450 patients with psychotic depression will be randomly assigned to receive either mifepristone or matching placebo. Patients will be assessed by the investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.

Arms:
arm 1: Mifepristone followed by an antidepressant arm 2: Placebo followed by an antidepressant

Interventions: intervention 1: mifepristone intervention 2: placebo
Intervention descriptions: intervention 1: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days intervention 2: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Protocol document: