Borderline Personality DisorderPhase 2NCT01212588
Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)
A Phase 2 study testing mifepristone in people with Borderline Personality Disorder, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 years of age at study entry
- Female or Male
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of borderline personality disorder (confirmed by SCID II) with history of abuse prior to the age of 18.
- Able to provide informed consent
- Inpatient or outpatient
- Clinical stability as defined by:
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- Subjects must not have experienced an exacerbation of their illness within 4 weeks prior to randomization, leading to an intensification of psychiatric care in the opinion of the principal investigator. Examples of intensification of care include, but are not limited to: inpatient hospitalization, day/partial hospitalization, outpatient crisis management, or psychiatric treatment in an emergency room AND
- Psychotropic treatment stability for at least 2 weeks prior to randomization (no change in dosing or addition of any new psychotropic medication)
- Female subjects of childbearing potential must test negative for pregnancy at screening visit and agree to use the double-barrier method, as defined by 2 physical barriers such as a condom, diaphragm, or cervical occlusive cap, coupled with an additional barrier such as spermicidal foam, gel, film, cream or suppository for the duration of the study. Subjects having undergone a hysterectomy or bilateral oophorectomy or other form of female sterilization or patients having been medically confirmed to be post-menopausal, would not require any other method of contraception.
- Minimum severity of a total score > 3 on the The Clinical Global Impression severity (CGI-S)
- Must agree not to consume tonic water and grapefruit or grapefruit product for 3 days prior to beginning medication and until the final study visit
Who cannot join
- DSM-IV TR diagnosis of (confirmed by SCID) schizophrenia or a related psychotic disorder, bipolar I disorder, or dementia
- Subjects who are considered prisoners per the Indiana University Standard Operating Procedures for Research Involving Human Subjects.
- Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, Chronic obstructive pulmonary disease (COPD), severe hypertriglyceridemia, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, renal gastroenterologic, respiratory, endocrinologic (particularly illnesses related to the HPA-axis, e.g., Cushing's Syndrome), neurologic, hematologic, or infectious diseases
- Clinically significant electrocardiogram (ECG) abnormality prior to randomization including: subjects with a corrected QT interval (Bazett's; QTcB) >470 msec prior to randomization (based on the cardiologist overread). Repeat ECGs will be conducted at the discretion of the principal investigator or medical designee
- Use of any exclusionary medications listed in the protocol Attachment 2: Concomitant Medications
- Pregnant or lactating women or women who plan to become pregnant or will be lactating within one month after cessation of study medication
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- Known Intelligence quotient (IQ) <70 based on medical history
- Currently using an intrauterine device (IUD) (females only)
- History of treatment with mifepristone or any mifepristone-containing medication at any time
- Known history of (1) Hepatitis C virus antibody, (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody, or (3) HIV 1 or 2 antibodies
- Subjects with moderate to severe renal impairment as defined by creatinine clearance (CrCl) < 60 ml/min (measured by the Cockcroft-Gault equation) at screening
- Subjects with hepatic impairment as defined by liver transaminases or total bilirubin > 3 × upper limit of normal (ULN)
- Subjects considered a high risk for suicidal acts, as determined by the principal investigator.
- Subjects who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the 4 weeks prior to screening OR Subjects currently receiving treatment (within 1 dosing interval plus 4 weeks) with an investigational depot formulation of an antipsychotic medication
- Subjects who demonstrate overtly aggressive behavior or who are deemed to pose a homicidal risk in the principal investigator's opinion
- Psychosocial treatment changes 14 days prior to randomization
- History of unexplained vaginal bleeding, endometrial hyperplasia with atypia, or endometrial carcinoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Larue D Carter Memorial Hospital
Indianapolis, Indiana, 46222
About this study
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.
Read the 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, 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- mifepristone, Placebo
- Keywords
- BPD, Borderline, personality disorder, mifepristone
- Medical subject headings
- Borderline Personality Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristoneDrug
Mifepristone 600mg (3x200mg tablets) once daily for seven days
PlaceboDrug
3 tablets once daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Mifepristone 600mg once daily x 7 days Receives: Drug: mifepristone |
| Placebo | Placebo comparator | Matching placebo tablets one daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Symptom Change
To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Measured: Baseline to 7 days of study medication
Durable Symptom Change
To evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Measured: 7 days of study medication to 21 days after discontinuation of study medication
Number of Participants With Possibly and Probably Related Adverse Events
To determine the safety and tolerability of mifepristone according to subject report of possibly and probably related adverse events (AEs). AEs were evaluated by study physicians at each visit and each reported AE was evaluated for relatedness (unrelated, possibly related, or probably related) to the study drug/procedure.
Measured: Baseline to 21 days after discontinuation of study medication
Levels of Cortisol
To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement
Measured: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)
Secondary outcomes (11)
Symptom Change - BPDSI Subscales
Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.
Measured: Baseline (Visit 2)
Symptom Change - BPRS
The Brief Psychiatric Rating Scale (BPRS) is an 19-item scale measuring positive symptoms, general psychopathology and affective symptoms during the last 7 days. The BPRS measures symptoms with scores ranging from 0-7, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 0-133, with a higher score indicating more severity.
Measured: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - Borderline Checklist
The Borderline Personality Checklist (BPD Checklist) is a 47-item DSM-IV based self-report questionnaire, designed to assess the experienced burden of specific BPD symptoms during the previous week. The BPD Checklist measures symptoms with scores ranging from 1-5, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 47-235, with a higher score indicating more severity.
Measured: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - SCL-90-R
The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.
Measured: Baseline (Visit 2)
Metacognitive Capacity
The Indiana Psychiatric Illness Interview (IPII) is a semi-structured interview developed to assess illness narratives. Responses are audio taped and later transcribed. It is scored using the Metacognition Assessment Scale- Abbreviated (MAS-A), which has four domains of metacognition: i) Self-Reflectivity ranging from 0-9; ii) Understanding the Mind of Other ranging from 0-7; iii) Decentration ranging from 0-3; and iv) Mastery ranging from 0-9. Lower scores indicate metacognitive deficits, higher scores indicate more integrated and nuanced metacognition. MAS-A total score is the sum of the scores on each of the domains of metacognition, ranging from 0-28, with a lower score indicating metacognitive deficits and a higher score indicating more integrated and nuanced metacognition.
Measured: Baseline, 21 days after discontinuation of study medication
Symptom Change - CGI-S
The Clinical Global Impressions Severity Scale (CGI-S) is used for repeated evaluations of global psychopathology. The CGI-S scale is widely used in schizophrenia research and is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill), with a higher score indicating more severity.
Measured: Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - CGI-I
The Clinical Global Impressions Improvement (CGI-I) scale is used to assess the clinical change as compared to symptoms at baseline using a 7-point Likert scale, ranging from very much improved (1) to very much worse (7), with a higher score indicating more severity.
Measured: 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - BPDSI Subscales
Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.
Measured: 7 days of study medication (Visit 4)
Symptom Change - BPDSI Subscales
Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.
Measured: 21 days after discontinuation of study medication (Visit 6)
Symptom Change - SCL-90-R
The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.
Measured: 7 days of study medication (Visit 4)
Symptom Change - SCL-90-R
The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.
Measured: 21 days after discontinuation of study medication (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Breier, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212588
- Sponsor's protocol ID
- 1011002977
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2010
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01212588
- Acronym / sponsor ID
- 1011002977
- Conditions
- Borderline Personality Disorder
- Keywords
- BPD, Borderline, personality disorder, mifepristone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: mifepristoneMifepristone 600mg once daily x 7 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablets one daily |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18-64 years of age at study entry
- Female or Male
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of borderline personality disorder (confirmed by SCID II) with history of abuse prior to the age of 18.
- Able to provide informed consent
- Inpatient or outpatient
Key exclusion criteria (17 listed)
- DSM-IV TR diagnosis of (confirmed by SCID) schizophrenia or a related psychotic disorder, bipolar I disorder, or dementia
- Subjects who are considered prisoners per the Indiana University Standard Operating Procedures for Research Involving Human Subjects.
- Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, Chronic obstructive pulmonary disease (COPD), severe hypertriglyceridemia, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, renal gastroenterologic, respiratory, endocrinologic (particularly illnesses related to the HPA-axis, e.g., Cushing's Syndrome), neurologic, hematologic, or infectious diseases
- Clinically significant electrocardiogram (ECG) abnormality prior to randomization including: subjects with a corrected QT interval (Bazett's; QTcB) >470 msec prior to randomization (based on the cardiologist overread). Repeat ECGs will be conducted at the discretion of the principal investigator or medical designee
- Use of any exclusionary medications listed in the protocol Attachment 2: Concomitant Medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mifepristoneMifepristone 600mg (3x200mg tablets) once daily for seven days | Drug | Mifepristone |
| Placebo3 tablets once daily for seven days | Drug | Placebo |
Primary outcome
Rapid Symptom Change
Time frame: Baseline to 7 days of study medication
To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Durable Symptom Change
Time frame: 7 days of study medication to 21 days after discontinuation of study medication
To evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Number of Participants With Possibly and Probably Related Adverse Events
Time frame: Baseline to 21 days after discontinuation of study medication
To determine the safety and tolerability of mifepristone according to subject report of possibly and probably related adverse events (AEs). AEs were evaluated by study physicians at each visit and each reported AE was evaluated for relatedness (unrelated, possibly related, or probably related) to the study drug/procedure.
Levels of Cortisol
Time frame: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)
To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement
11 secondary outcomes
Symptom Change - BPDSI Subscales
Time frame: Baseline (Visit 2)
Symptom Change - BPRS
Time frame: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - Borderline Checklist
Time frame: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - SCL-90-R
Time frame: Baseline (Visit 2)
Metacognitive Capacity
Time frame: Baseline, 21 days after discontinuation of study medication
Symptom Change - CGI-S
Time frame: Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - CGI-I
Time frame: 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)
Symptom Change - BPDSI Subscales
Time frame: 7 days of study medication (Visit 4)
Symptom Change - BPDSI Subscales
Time frame: 21 days after discontinuation of study medication (Visit 6)
Symptom Change - SCL-90-R
Time frame: 7 days of study medication (Visit 4)
Symptom Change - SCL-90-R
Time frame: 21 days after discontinuation of study medication (Visit 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mifepristone in people with Borderline Personality Disorder, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Symptom Change (time frame: Baseline to 7 days of study medication). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.