mifepristone for Psychotic Major Depression (PMD)?

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erg923

Regional Clinical Officer, Centene Corporation
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Just wondering what the consensus is among residents and those practicing on the prospects of using mifepristone for Psychotic Major Depression (PMD). I understand that it is not available at the present time (In the US at least), except for in research trials. The literature I have seen has been positive, but I noticed almost all the studies (very few) I could find on a lit search suffer from questionable methodology and/or interpretation. I noticed this outright reading the articles, but also read formal critiques in response to several articles. The attached link is just one example. I am curious because I am considering a research practicum at one of the few places that is doing these open label studies. The critique attached is targeted at the group of researchers I would be working with. I am a clinical psych grad student, so I would have pretty much nothing to do with the psychopharm aspect of the study, just the cognitive/neuropsych screenings section. Just wanted to see what the consensus is from psychiatrists/residents practicing out there.

http://www.nature.com/npp/journal/v31/n12/full/1301170a.html
 
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I don't see the niche of this drug indication doing well. To convince psychiatrist that this is worth prescribing (and the drug carries a sort of transference with it), you'll have to convince them that this is significantly more effective, over the longer term, than antipsychotics plus antidepressants in combination, which we're already very comfortable with. My gut tells me this is never getting FDA approval for this indication (psychotic major depression). Lots of drugs undergo such preliminary trials. Few either come to market or get the indication. To me, it seems that HPA dysregulation is another interesting physiological effect which could lead to psychiatric disturbance. However, I think it's likely to remain a scientific curiosity, and will likely not mainstream into an avenue for pharmacological intervention in this sense. Of course, I could be wrong. Look at Lamictal, after all.

Response to the prior letter.
 
Interesting. However it was my understanding that looking at this as several case studies (rather than as a clincial trial), the alleviation of both depressive and psychotic symptomatology was dramatic and quick to say the least in some of the patients (.ie., effect sizes). However, as I said, as a full clinical trial, I think it lacks internal validity due to several methodological problems, but again that was not the purpose of the study anyway. I know Dr. Keller very well from my work their, although I don't currently work in their group (yet at least).
 
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