Borderline Personality Disorder
Conditions
Keywords
BPD, Borderline, personality disorder, mifepristone
Brief 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.
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.
Interventions
DRUGmifepristone
Mifepristone 600mg (3x200mg tablets) once daily for seven days
DRUGPlacebo
3 tablets once daily for seven days
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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: * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rapid Symptom Change | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metacognitive Capacity | Baseline, 21 days after discontinuation of study medication | 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. |
| Symptom Change - BPDSI Subscales | Baseline (Visit 2) | 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. |
| Symptom Change - CGI-I | 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6) | 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. |
| Symptom Change - CGI-S | Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6) | 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. |
| Symptom Change - BPRS | 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) | 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. |
| Symptom Change - Borderline Checklist | 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) | 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. |
| Symptom Change - SCL-90-R | Baseline (Visit 2) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mifepristone Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days | 10 |
| Placebo Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Mifepristone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Continuous | 40.90 years STANDARD_DEVIATION 11.75 | 33.42 years STANDARD_DEVIATION 10.33 | 36.82 years STANDARD_DEVIATION 11.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 12 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 17 Participants |
| Region of Enrollment United States | 10 participants | 12 participants | 22 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 10 / 10 | 10 / 12 |
| serious Total, serious adverse events | 0 / 10 | 1 / 12 |
Outcome results
Primary
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.
Time frame: 7 days of study medication to 21 days after discontinuation of study medication
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Durable Symptom Change | BPDSI Total Score after 7 days of medication | 13.50 Scores on a scale | Standard Deviation 7.93 |
| Mifepristone | Durable Symptom Change | BPDSI Total Score 21 days after discont. study med | 13.58 Scores on a scale | Standard Deviation 5.31 |
| Placebo | Durable Symptom Change | BPDSI Total Score after 7 days of medication | 9.45 Scores on a scale | Standard Deviation 4.24 |
| Placebo | Durable Symptom Change | BPDSI Total Score 21 days after discont. study med | 8.17 Scores on a scale | Standard Deviation 4.32 |
Primary
Levels of Cortisol
To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Levels of Cortisol | Cortisol Level - Baseline | 13.88 mcg/dL | Standard Deviation 5.39 |
| Mifepristone | Levels of Cortisol | Cortisol Level - 7 days of study med | 35.01 mcg/dL | Standard Deviation 17.41 |
| Mifepristone | Levels of Cortisol | Cortisol Level - 7 days after disc of study med | 20.91 mcg/dL | Standard Deviation 5.53 |
| Mifepristone | Levels of Cortisol | Cortisol Level - 21 days after disc study med | 11.90 mcg/dL | Standard Deviation 4.95 |
| Placebo | Levels of Cortisol | Cortisol Level - 21 days after disc study med | 15.73 mcg/dL | Standard Deviation 12 |
| Placebo | Levels of Cortisol | Cortisol Level - Baseline | 14.38 mcg/dL | Standard Deviation 8.58 |
| Placebo | Levels of Cortisol | Cortisol Level - 7 days after disc of study med | 14.30 mcg/dL | Standard Deviation 6.88 |
| Placebo | Levels of Cortisol | Cortisol Level - 7 days of study med | 16.33 mcg/dL | Standard Deviation 9.5 |
Primary
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.
Time frame: Baseline to 21 days after discontinuation of study medication
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mifepristone | Number of Participants With Possibly and Probably Related Adverse Events | Number of subjects with possibly related AEs | 9 Participants |
| Mifepristone | Number of Participants With Possibly and Probably Related Adverse Events | Number of subjects with probably related AEs | 3 Participants |
| Placebo | Number of Participants With Possibly and Probably Related Adverse Events | Number of subjects with possibly related AEs | 6 Participants |
| Placebo | Number of Participants With Possibly and Probably Related Adverse Events | Number of subjects with probably related AEs | 3 Participants |
Primary
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.
Time frame: Baseline to 7 days of study medication
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Rapid Symptom Change | BPDSI Total Score after 7 days of medication | 13.5 Scores on a scale | Standard Deviation 7.93 |
| Mifepristone | Rapid Symptom Change | BPDSI Total Score at Baseline | 17.99 Scores on a scale | Standard Deviation 6.65 |
| Placebo | Rapid Symptom Change | BPDSI Total Score after 7 days of medication | 9.45 Scores on a scale | Standard Deviation 4.24 |
| Placebo | Rapid Symptom Change | BPDSI Total Score at Baseline | 13.66 Scores on a scale | Standard Deviation 7.72 |
Secondary
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.
Time frame: Baseline, 21 days after discontinuation of study medication
Population: The IPII assessment was added to the study midway through the study therefore, the first 10 subjects did not have this assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Metacognitive Capacity | IIPI - Self-Reflectivity - Baseline | 5.08 Scores on a scale | Standard Deviation 1.63 |
| Mifepristone | Metacognitive Capacity | IIPI-Self-Reflectivity-21 days after dis study med | 5.25 Scores on a scale | Standard Deviation 1.89 |
| Mifepristone | Metacognitive Capacity | IIPI - Understanding Others - Baseline | 3.25 Scores on a scale | Standard Deviation 1.08 |
| Mifepristone | Metacognitive Capacity | IIPI-Understanding Others-21 days after dis meds | 2.75 Scores on a scale | Standard Deviation 0.5 |
| Mifepristone | Metacognitive Capacity | IIPI - Decentration - Baseline | 0.50 Scores on a scale | Standard Deviation 0.45 |
| Mifepristone | Metacognitive Capacity | IIPI-Decentration-21 days after dis meds | 0.38 Scores on a scale | Standard Deviation 0.75 |
| Mifepristone | Metacognitive Capacity | IIPI - Mastery - Baseline | 2.67 Scores on a scale | Standard Deviation 1.89 |
| Mifepristone | Metacognitive Capacity | IIPI-Mastery-21 days after dis meds | 2.75 Scores on a scale | Standard Deviation 0.5 |
| Mifepristone | Metacognitive Capacity | IIPI - Total - Baseline | 11.50 Scores on a scale | Standard Deviation 4.69 |
| Mifepristone | Metacognitive Capacity | IIPI-Total-21 days after dis meds | 11.13 Scores on a scale | Standard Deviation 2.95 |
| Placebo | Metacognitive Capacity | IIPI-Mastery-21 days after dis meds | 2.80 Scores on a scale | Standard Deviation 1.64 |
| Placebo | Metacognitive Capacity | IIPI - Self-Reflectivity - Baseline | 4.63 Scores on a scale | Standard Deviation 1.7 |
| Placebo | Metacognitive Capacity | IIPI-Decentration-21 days after dis meds | 0.20 Scores on a scale | Standard Deviation 0.45 |
| Placebo | Metacognitive Capacity | IIPI-Self-Reflectivity-21 days after dis study med | 3.90 Scores on a scale | Standard Deviation 0.42 |
| Placebo | Metacognitive Capacity | IIPI-Total-21 days after dis meds | 9.40 Scores on a scale | Standard Deviation 2.43 |
| Placebo | Metacognitive Capacity | IIPI - Understanding Others - Baseline | 2.88 Scores on a scale | Standard Deviation 1.31 |
| Placebo | Metacognitive Capacity | IIPI - Mastery - Baseline | 3.88 Scores on a scale | Standard Deviation 2.1 |
| Placebo | Metacognitive Capacity | IIPI-Understanding Others-21 days after dis meds | 2.50 Scores on a scale | Standard Deviation 1 |
| Placebo | Metacognitive Capacity | IIPI - Total - Baseline | 11.75 Scores on a scale | Standard Deviation 4.99 |
| Placebo | Metacognitive Capacity | IIPI - Decentration - Baseline | 0.38 Scores on a scale | Standard Deviation 0.48 |
Secondary
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - Borderline Checklist | BPD Checklist - Baseline | 103.60 Scores on a scale | Standard Deviation 30.83 |
| Mifepristone | Symptom Change - Borderline Checklist | BPD Checklist - 7 days of study med | 98.10 Scores on a scale | Standard Deviation 27.22 |
| Mifepristone | Symptom Change - Borderline Checklist | BPD Checklist - 7 days after disc of study med | 91.56 Scores on a scale | Standard Deviation 26.74 |
| Mifepristone | Symptom Change - Borderline Checklist | BPD Checklist - 21 days after disc study med | 87.89 Scores on a scale | Standard Deviation 24.31 |
| Placebo | Symptom Change - Borderline Checklist | BPD Checklist - 21 days after disc study med | 78.80 Scores on a scale | Standard Deviation 28.01 |
| Placebo | Symptom Change - Borderline Checklist | BPD Checklist - Baseline | 96.92 Scores on a scale | Standard Deviation 26.29 |
| Placebo | Symptom Change - Borderline Checklist | BPD Checklist - 7 days after disc of study med | 82.80 Scores on a scale | Standard Deviation 37.94 |
| Placebo | Symptom Change - Borderline Checklist | BPD Checklist - 7 days of study med | 88.36 Scores on a scale | Standard Deviation 32.02 |
Secondary
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.
Time frame: 7 days of study medication (Visit 4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Interpersonal Relationships | 0.80 Scores on a scale | Standard Deviation 0.54 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Affective Instability | 3.67 Scores on a scale | Standard Deviation 2.43 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Impulsivity | 0.66 Scores on a scale | Standard Deviation 0.64 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Emptiness | 2.76 Scores on a scale | Standard Deviation 1.81 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Identity | 1.64 Scores on a scale | Standard Deviation 1.13 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Outbursts of Anger | 1.08 Scores on a scale | Standard Deviation 1.2 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Parasuicidal Behavior | 0.37 Scores on a scale | Standard Deviation 0.52 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Sub. Score-Dissociation & Paranoid Ideation | 1.63 Scores on a scale | Standard Deviation 1.26 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Abandonment | 0.90 Scores on a scale | Standard Deviation 0.59 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Sub. Score-Dissociation & Paranoid Ideation | 0.77 Scores on a scale | Standard Deviation 0.84 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Abandonment | 1.27 Scores on a scale | Standard Deviation 1.15 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Interpersonal Relationships | 0.58 Scores on a scale | Standard Deviation 0.53 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Identity | 1.34 Scores on a scale | Standard Deviation 0.85 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Impulsivity | 0.11 Scores on a scale | Standard Deviation 0.17 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Parasuicidal Behavior | 0.19 Scores on a scale | Standard Deviation 0.37 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Affective Instability | 2.89 Scores on a scale | Standard Deviation 1.9 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Emptiness | 1.51 Scores on a scale | Standard Deviation 0.91 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Outbursts of Anger | 0.79 Scores on a scale | Standard Deviation 0.92 |
Secondary
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.
Time frame: Baseline (Visit 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Interpersonal Relationships | 1.34 Scores on a scale | Standard Deviation 0.91 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Affective Instability | 4.40 Scores on a scale | Standard Deviation 1.79 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Impulsivity | 0.78 Scores on a scale | Standard Deviation 0.62 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Emptiness | 3.96 Scores on a scale | Standard Deviation 2.17 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Identity | 2.76 Scores on a scale | Standard Deviation 1.14 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Outbursts of Anger | 1.45 Scores on a scale | Standard Deviation 1.27 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Parasuicidal Behavior | 0.48 Scores on a scale | Standard Deviation 0.62 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Sub. Score-Dissociation & Paranoid Ideation | 1.45 Scores on a scale | Standard Deviation 0.98 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Abandonment | 1.46 Scores on a scale | Standard Deviation 0.96 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Sub. Score-Dissociation & Paranoid Ideation | 1.14 Scores on a scale | Standard Deviation 1.28 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Abandonment | 1.36 Scores on a scale | Standard Deviation 1.55 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Interpersonal Relationships | 0.70 Scores on a scale | Standard Deviation 0.77 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Identity | 1.49 Scores on a scale | Standard Deviation 1.34 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Impulsivity | 0.32 Scores on a scale | Standard Deviation 0.37 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Parasuicidal Behavior | 0.30 Scores on a scale | Standard Deviation 0.46 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Affective Instability | 4.48 Scores on a scale | Standard Deviation 2.41 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Emptiness | 2.35 Scores on a scale | Standard Deviation 1.39 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Outbursts of Anger | 1.53 Scores on a scale | Standard Deviation 2.36 |
Secondary
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.
Time frame: 21 days after discontinuation of study medication (Visit 6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Interpersonal Relationships | 0.84 Scores on a scale | Standard Deviation 0.86 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Affective Instability | 3.27 Scores on a scale | Standard Deviation 2.1 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Impulsivity | 0.53 Scores on a scale | Standard Deviation 0.58 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Emptiness | 2.94 Scores on a scale | Standard Deviation 1.86 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Identity | 1.92 Scores on a scale | Standard Deviation 1.12 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Outbursts of Anger | 0.97 Scores on a scale | Standard Deviation 1.22 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Parasuicidal Behavior | 0.43 Scores on a scale | Standard Deviation 0.38 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Sub. Score-Dissociation & Paranoid Ideation | 1.62 Scores on a scale | Standard Deviation 1.03 |
| Mifepristone | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Abandonment | 1.06 Scores on a scale | Standard Deviation 0.75 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Sub. Score-Dissociation & Paranoid Ideation | 0.56 Scores on a scale | Standard Deviation 0.58 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Abandonment | 0.63 Scores on a scale | Standard Deviation 0.67 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Interpersonal Relationships | 0.64 Scores on a scale | Standard Deviation 0.88 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Identity | 0.63 Scores on a scale | Standard Deviation 0.76 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Impulsivity | 0.11 Scores on a scale | Standard Deviation 0.14 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Parasuicidal Behavior | 0.25 Scores on a scale | Standard Deviation 0.37 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Affective Instability | 2.96 Scores on a scale | Standard Deviation 1.6 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Emptiness | 1.79 Scores on a scale | Standard Deviation 1.67 |
| Placebo | Symptom Change - BPDSI Subscales | BPDSI Subscale Score - Outbursts of Anger | 0.62 Scores on a scale | Standard Deviation 1.07 |
Secondary
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - BPRS | BPRS - Baseline | 37.70 Scores on a scale | Standard Deviation 5.85 |
| Mifepristone | Symptom Change - BPRS | BPRS - 7 days of study medication | 33.90 Scores on a scale | Standard Deviation 6.15 |
| Mifepristone | Symptom Change - BPRS | BPRS - 7 days after disc of study med | 35.78 Scores on a scale | Standard Deviation 6.57 |
| Mifepristone | Symptom Change - BPRS | BPRS - 21 days after disc study med | 35.22 Scores on a scale | Standard Deviation 6.34 |
| Placebo | Symptom Change - BPRS | BPRS - 21 days after disc study med | 30.50 Scores on a scale | Standard Deviation 5.44 |
| Placebo | Symptom Change - BPRS | BPRS - Baseline | 37.50 Scores on a scale | Standard Deviation 7.09 |
| Placebo | Symptom Change - BPRS | BPRS - 7 days after disc of study med | 33.50 Scores on a scale | Standard Deviation 7.66 |
| Placebo | Symptom Change - BPRS | BPRS - 7 days of study medication | 33.36 Scores on a scale | Standard Deviation 7.3 |
Secondary
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.
Time frame: 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)
Population: The CGI-I is measured at visits after baseline, there was 1 subject taking Placebo who discontinued prior to Visit 4 and therefore was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - CGI-I | CGI-I - 7 days of study med | 3.30 Scores on a scale | Standard Deviation 1.16 |
| Mifepristone | Symptom Change - CGI-I | CGI-I - 21 days after disc of study med | 3.44 Scores on a scale | Standard Deviation 1.01 |
| Placebo | Symptom Change - CGI-I | CGI-I - 7 days of study med | 3.36 Scores on a scale | Standard Deviation 1.29 |
| Placebo | Symptom Change - CGI-I | CGI-I - 21 days after disc of study med | 2.80 Scores on a scale | Standard Deviation 1.14 |
Secondary
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.
Time frame: Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - CGI-S | CGI-S - Baseline | 4.30 Scores on a scale | Standard Deviation 0.67 |
| Mifepristone | Symptom Change - CGI-S | CGI-S - 7 days of study med | 4.20 Scores on a scale | Standard Deviation 1.03 |
| Mifepristone | Symptom Change - CGI-S | CGI-S - 21 days after disc of study med | 3.89 Scores on a scale | Standard Deviation 0.93 |
| Placebo | Symptom Change - CGI-S | CGI-S - Baseline | 4.42 Scores on a scale | Standard Deviation 0.9 |
| Placebo | Symptom Change - CGI-S | CGI-S - 7 days of study med | 4.09 Scores on a scale | Standard Deviation 1.04 |
| Placebo | Symptom Change - CGI-S | CGI-S - 21 days after disc of study med | 3.70 Scores on a scale | Standard Deviation 0.95 |
Secondary
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.
Time frame: 21 days after discontinuation of study medication (Visit 6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Anxiety | 48.44 Scores on a scale | Standard Deviation 9.25 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Hostility | 50.11 Scores on a scale | Standard Deviation 12.5 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Phobic Anxiety | 46.00 Scores on a scale | Standard Deviation 6.96 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Paranoid Ideation | 50.33 Scores on a scale | Standard Deviation 10.48 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Psychoticism | 45.44 Scores on a scale | Standard Deviation 8.5 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Global Severity Index | 49.00 Scores on a scale | Standard Deviation 10.3 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Total | 49.56 Scores on a scale | Standard Deviation 11.22 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Distress Index | 51.67 Scores on a scale | Standard Deviation 13.19 |
| Mifepristone | Symptom Change - SCL-90-R | SCl-90-R - Somatization | 49.78 Scores on a scale | Standard Deviation 15.21 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Obsessive-Complusive | 51.33 Scores on a scale | Standard Deviation 9.8 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Interpersonal Sensitivity | 48.89 Scores on a scale | Standard Deviation 10.48 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Depression | 49.00 Scores on a scale | Standard Deviation 9.86 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Interpersonal Sensitivity | 45.30 Scores on a scale | Standard Deviation 8.79 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Anxiety | 42.70 Scores on a scale | Standard Deviation 10.27 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Total | 44.80 Scores on a scale | Standard Deviation 10.4 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Hostility | 48.80 Scores on a scale | Standard Deviation 6.84 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Obsessive-Complusive | 44.60 Scores on a scale | Standard Deviation 12.69 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Phobic Anxiety | 50.10 Scores on a scale | Standard Deviation 8.75 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Distress Index | 46.60 Scores on a scale | Standard Deviation 12.47 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Paranoid Ideation | 46.80 Scores on a scale | Standard Deviation 12.56 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Depression | 44.00 Scores on a scale | Standard Deviation 12.44 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Psychoticism | 45.70 Scores on a scale | Standard Deviation 13.31 |
| Placebo | Symptom Change - SCL-90-R | SCl-90-R - Somatization | 47.60 Scores on a scale | Standard Deviation 10.7 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Global Severity Index | 45.10 Scores on a scale | Standard Deviation 12.05 |
Secondary
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.
Time frame: Baseline (Visit 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - SCL-90-R | SCl-90-R - Somatization | 55.80 Scores on a scale | Standard Deviation 6.18 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Obsessive-Complusive | 56.20 Scores on a scale | Standard Deviation 8.48 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Interpersonal Sensitivity | 56.50 Scores on a scale | Standard Deviation 12.19 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Depression | 54.40 Scores on a scale | Standard Deviation 8.91 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Anxiety | 52.60 Scores on a scale | Standard Deviation 9.09 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Hostility | 53.70 Scores on a scale | Standard Deviation 8.54 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Phobic Anxiety | 50.00 Scores on a scale | Standard Deviation 8.94 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Paranoid Ideation | 56.40 Scores on a scale | Standard Deviation 9.75 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Psychoticism | 52.20 Scores on a scale | Standard Deviation 9.37 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Global Severity Index | 55.20 Scores on a scale | Standard Deviation 9.16 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Total | 55.90 Scores on a scale | Standard Deviation 10.72 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Distress Index | 54.50 Scores on a scale | Standard Deviation 7.49 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Total | 49.00 Scores on a scale | Standard Deviation 7.95 |
| Placebo | Symptom Change - SCL-90-R | SCl-90-R - Somatization | 50.25 Scores on a scale | Standard Deviation 9.96 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Phobic Anxiety | 54.58 Scores on a scale | Standard Deviation 11.05 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Obsessive-Complusive | 51.50 Scores on a scale | Standard Deviation 9.04 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Global Severity Index | 50.00 Scores on a scale | Standard Deviation 8.42 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Interpersonal Sensitivity | 51.58 Scores on a scale | Standard Deviation 7.55 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Paranoid Ideation | 48.45 Scores on a scale | Standard Deviation 7.66 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Depression | 49.75 Scores on a scale | Standard Deviation 9.2 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Distress Index | 52.25 Scores on a scale | Standard Deviation 8.92 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Anxiety | 47.17 Scores on a scale | Standard Deviation 7.72 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Psychoticism | 47.67 Scores on a scale | Standard Deviation 8.55 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Hostility | 53.00 Scores on a scale | Standard Deviation 7.6 |
Secondary
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.
Time frame: 7 days of study medication (Visit 4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mifepristone | Symptom Change - SCL-90-R | SCl-90-R - Somatization | 53.00 Scores on a scale | Standard Deviation 10.92 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Obsessive-Complusive | 54.30 Scores on a scale | Standard Deviation 11.49 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Interpersonal Sensitivity | 53.00 Scores on a scale | Standard Deviation 10.07 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Depression | 52.60 Scores on a scale | Standard Deviation 9.32 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Anxiety | 49.10 Scores on a scale | Standard Deviation 10.08 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Hostility | 52.80 Scores on a scale | Standard Deviation 9.07 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Phobic Anxiety | 49.60 Scores on a scale | Standard Deviation 6.59 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Paranoid Ideation | 53.80 Scores on a scale | Standard Deviation 10.38 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Psychoticism | 48.80 Scores on a scale | Standard Deviation 8.16 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Global Severity Index | 52.30 Scores on a scale | Standard Deviation 9.89 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Total | 53.40 Scores on a scale | Standard Deviation 11.89 |
| Mifepristone | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Distress Index | 54.20 Scores on a scale | Standard Deviation 11.49 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Total | 46.91 Scores on a scale | Standard Deviation 9.69 |
| Placebo | Symptom Change - SCL-90-R | SCl-90-R - Somatization | 46.27 Scores on a scale | Standard Deviation 9.18 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Phobic Anxiety | 49.55 Scores on a scale | Standard Deviation 7.88 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Obsessive-Complusive | 47.91 Scores on a scale | Standard Deviation 9.69 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Global Severity Index | 45.82 Scores on a scale | Standard Deviation 9.29 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Interpersonal Sensitivity | 48.45 Scores on a scale | Standard Deviation 10.05 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Paranoid Ideation | 47.91 Scores on a scale | Standard Deviation 8.88 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Depression | 47.82 Scores on a scale | Standard Deviation 10.05 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Positive Symptom Distress Index | 51.91 Scores on a scale | Standard Deviation 17.04 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Anxiety | 43.09 Scores on a scale | Standard Deviation 9.39 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Psychoticism | 47.27 Scores on a scale | Standard Deviation 10.67 |
| Placebo | Symptom Change - SCL-90-R | SCL-90-R - Hostility | 52.00 Scores on a scale | Standard Deviation 10.85 |