Borderline Personality Disorder Clinical Trial
Official title:
Preliminary, Double Blind, Placebo Controlled Trial of the Effect of Glucocorticoid Receptor Antagonist Treatment on Biologic and Symptom Outcomes in Patients With Borderline Personality Disorder and Histories of Childhood Abuse
Participants will be randomized to either Mifepristone 600mg once daily for seven days or Placebo tablet once daily for seven days. Rating scales, vital signs, cortisol levels will be collected for evaluation.
Mifepristone is an antagonist of type II glucocorticoid (GR-II) receptors, which has shown
safety, efficacy, and good tolerability in the treatment of psychotic major depression (PMD).
Like BPD, Hypothalamic-pituitary-adrenal (HPA) axis hyper-responsiveness appears to play a
role in PMD pathophysiology. Belanoff et al. (2002) hypothesized that mifepristone causes a
normalizing "resetting" of HPA axis rhythm, accounting for its efficacy in PMD. Mifepristone
produces a marked (2- to 3- fold) compensatory increase in central cortisol levels via its
antagonism of GR-II receptors. This consequent central cortisol elevation may then be able to
counteract abnormally heightened corticotrophin-releasing hormone (CRH) activity via enhanced
negative feedback mechanisms.
This is a proof of principle study of mifepristone in the treatment of individuals with BPD
and histories of childhood abuse, which aims to translate neurobiological research concerning
HPA axis abnormalities in BPD into a novel clinical intervention for patients. This project
will also explore an innovative approach to the structure of pharmacotherapy for BPD.
Specifically, we will employ the circumscribed (finite) drug administration period used in
prior studies of mifepristone in neuropsychiatric illness, which differs from the current
clinical practice of indefinite daily usage of medications. We hypothesize that mifepristone
will beneficially impact stress response neurobiology and consequently ameliorate associated
BPD symptoms.
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