This is a double-blind, placebo-controlled study of the efficacy and safety of CORLUX (Mifepristone) versus placebo in the treatment of psychotic symptoms in patients with Major Depressive Disorder with Psychotic Features.
Subjects will be men and women ages 22 - 75 who meet criteria for a DSM-IV diagnosis of Major Depressive Disorder with Psychotic Features and are clinically symptomatic with their illness. Subjects will be randomly assigned to receive either CORLUX or matching placebo for days 1 - 7, and will receive one of four antidepressants for the remainder of the study. The entire study will take up to 70 days to complete. Subjects may not be taking antidepressants or antipsychotic medications (or they must discontinue taking these medications at screening) in order to qualify for the study. Subjects must not have received ECT within the past three months prior to screening in order to participate in the study.
Once a patient has attended the screening visit and has been determined to be eligible for the study, they will return for the baseline visit and then daily for the next seven days. From this point forward, study visits will occur every two weeks at the study site.
Who should I contact for more information? Please contact Kelly Moore, Central Study Coordinator at (919) 733-5227 and mention the TOPS study.