OPEN-LABEL TREATMENT OF SCHIZOFFECTIVE DISORDER USING MIFEPRISTONE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study proposes using Mifepristone on a compassionate use basis for patients diagnosed with either schizoaffective disorder or major depression with psychotic features. In screening potential patients for our previous studies, we have encountered a significant number who decline study participation because they could not be assured that they would receive active medication. In addition, past participants in our current Mifepristone-use study have expressed interest in receiving Mifepristone as part of an open-label clinical drug trial. Although we feel that double-blind, placebo-controlled studies are the "gold standard" to measure efficacy, we also feel that patients with severe affective psychoses may be helped significantly by Mifepristone. The data obtained in an open-label study will still be useful. Our aim is to test the hypothesis that Mifepristone will rapidly improve psychosis and altered cognition and mood in individuals diagnosed with either schizoaffective disorder or psychotic major depression. Research questions to be clarified by the data: a. Will Mifepristone rapidly improve the psychosis, altered cognition, and mood-component of individuals diagnosed with either schizoaffective disorder or psychotic major depression? b. Do levels of cortisol, adenocorticotropic hormone (ACTH), and homovanillic acid (HVA) change (i.e., demonstrate a post-treatment decrease from baseline levels) in these subjects after being treated with Mifepristone?