Clinical Trial of Mifepristone for Bipolar Depression
Status:
Completed
Trial end date:
2007-06-25
Target enrollment:
Participant gender:
Summary
Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and
increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA)
hyperactivity are found in bipolar disorder related to depression and mixed states. Patients
with bipolar disorder also have cognitive difficulties and endocrine disturbances may
contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood
disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a
glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a
matter of days. In this study we examine the effects of mifepristone in severe bipolar
depression in a parallel, double blind placebo controlled experiment. Bipolar subjects
maintained on either lithium or valproate, after washout or prior antidepressants have a
detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight
days of mifepristone versus placebo after which patients are blindly crossed over to the
opposite arm. Patients and a group of matched controls approximately or almost 35 will be
compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize
their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA
axis hyperactivity and cognitive impairment will be predictive of response to
antiglucocorticoid therapy with mifepristone.