Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01212588
First received: September 29, 2010
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Borderline Personality Disorder
Drug: mifepristone
Drug: Placebo
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Symptom reduction [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    as per study assessments


Estimated Enrollment: 24
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)
Arms Assigned Interventions
Experimental: Mifepristone
Mifepristone 600mg once daily x 7 days
Drug: mifepristone
Mifepristone 600mg once daily for seven days
Placebo Comparator: Placebo
Matching placebo tablets one daily
Drug: Placebo
One tab daily for seven days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female gender
  • Age 18-55
  • History of Child Abuse Type: Physical □; Emotional □; Sexual □;
  • Stable Concomitant Medication, to remain stable throughout the study participation period.
  • Stable Psychosocial Treatment, to remain stable throughout the study participation period.
  • BPRSI 3 month score of > 20

Exclusion Criteria:

  • Primary psychotic disorder diagnosis, or PMD, Bipolar 1 Disorder, or dementia disorder.
  • IQ < 80
  • Substance dependence needing detoxification
  • Intrauterine device placement
  • HPA Axis related medical illness (i.e. Cushings Syndrome)
  • Steroid treatment of any kind (systemic, inhaled, or topical) in the past six months
  • Previous Mifepristone treatment
  • Any serious and/or unstable medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212588

Locations
United States, Indiana
Indiana University -- Indianapolis Campus
Indianapolis, Indiana, United States, 46201
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01212588     History of Changes
Other Study ID Numbers: 1005-11
Study First Received: September 29, 2010
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
BPD,
Borderline,
personality disorder
child abuse

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Glucocorticoids
Mifepristone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 22, 2014