Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)
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.
Borderline Personality Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Symptom reduction [ Time Frame: 28 days ] [ Designated as safety issue: No ]as per study assessments
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Mifepristone 600mg once daily x 7 days
Mifepristone 600mg once daily for seven days
Placebo Comparator: Placebo
Matching placebo tablets one daily
One tab daily for seven days
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, HPA axis hyper-responsiveness appears to play a role in PMD pathophysiology (7). Belanoff et al. (2002) hypothesized that mifepristone causes a normalizing "resetting" of HPA axis rhythm, accounting for its efficacy in PMD (8). 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 CRH activity via enhanced negative feedback mechanisms.
Participants will include females between the ages of 18-55 with BPD and histories of childhood abuse. BPD will be formally diagnosed with the Structured Clinical Interview for DSM-IV-TR (SCID) Axis II Disorders, and childhood abuse history will be assessed using the (clinician-administered) Interview for Traumatic Events in Childhood (ITEC). Included subjects will maintain their ongoing psychopharmacologic and psychosocial therapies without change during the study period.
Individuals with the following psychiatric diagnoses, assessed with the SCID for Axis I Disorders, will be excluded: (1) a primary psychotic disorder, namely schizophrenia, schizoaffective disorder, acute psychotic disorder, or delusional disorder, (2) psychotic major depression, (3) bipolar disorder, type I, (4) dementia or baseline intellectual impairment (IQ below 80), and (5) substance dependence necessitating medical detoxification. In addition, persons with an HPA axis related medical illness (e.g., Cushing's Syndrome), steroid treatment of any kind (systemic, inhaled, topical) in the previous 6 months, any prior mifepristone treatment, or a serious and/or unstable medical illness will be excluded. Given that mifepristone is an abortifacient owing to its anti-progesterone actions, this study will exclude any females who are pregnant, nursing a child, or of child-bearing age and do not provide verification of 2 specified forms of adequate birth control measures at two separate time points prior to experimental treatment initiation. These birth control measures will be confirmed at every study visit. All subjects will undergo 2 separate urine pregnancy tests prior to experimental treatment initiation. Finally, women with an intrauterine device (IUD) in place cannot take
Subjects will complete self rating scales, BPD checklist and SCL-09-R, as well as clinician rated scales, CGI-S/I, BPRSI, and ITEC. Cortisol levels will be drawn at Day 0, 7,14,and 28. Evaluations are complete at 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212588
|United States, Indiana|
|Indiana University -- Indianapolis Campus|
|Indianapolis, Indiana, United States, 46201|