Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01212588
Recruitment Status : Terminated (Funding ended)
First Posted : September 30, 2010
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Alan Breier, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Borderline Personality Disorder
Interventions Drug: mifepristone
Drug: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Period Title: Overall Study
Started 10 12
Completed 9 10
Not Completed 1 2
Reason Not Completed
Physician Decision             0             1
Protocol Violation             1             1
Arm/Group Title Mifepristone Placebo Total
Hide Arm/Group Description

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
1
  10.0%
0
   0.0%
1
   4.5%
Between 18 and 65 years
9
  90.0%
12
 100.0%
21
  95.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 22 participants
40.90  (11.75) 33.42  (10.33) 36.82  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
8
  80.0%
11
  91.7%
19
  86.4%
Male
2
  20.0%
1
   8.3%
3
  13.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
10
 100.0%
12
 100.0%
22
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
2
  16.7%
4
  18.2%
White
8
  80.0%
9
  75.0%
17
  77.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   8.3%
1
   4.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Rapid Symptom Change
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPDSI Total Score after 7 days of medication 13.5  (7.93) 9.45  (4.24)
BPDSI Total Score at Baseline 17.99  (6.65) 13.66  (7.72)
2.Primary Outcome
Title Durable Symptom Change
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPDSI Total Score after 7 days of medication 13.50  (7.93) 9.45  (4.24)
BPDSI Total Score 21 days after discont. study med 13.58  (5.31) 8.17  (4.32)
3.Primary Outcome
Title Number of Participants With Possibly and Probably Related Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Measure Type: Count of Participants
Unit of Measure: Participants
Number of subjects with possibly related AEs
9
  90.0%
6
  50.0%
Number of subjects with probably related AEs
3
  30.0%
3
  25.0%
4.Primary Outcome
Title Levels of Cortisol
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: mcg/dL
Cortisol Level - Baseline 13.88  (5.39) 14.38  (8.58)
Cortisol Level - 7 days of study med 35.01  (17.41) 16.33  (9.50)
Cortisol Level - 7 days after disc of study med 20.91  (5.53) 14.30  (6.88)
Cortisol Level - 21 days after disc study med 11.90  (4.95) 15.73  (12.00)
5.Secondary Outcome
Title Symptom Change - BPDSI Subscales
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPDSI Subscale Score - Abandonment 1.46  (0.96) 1.36  (1.55)
BPDSI Subscale Score - Interpersonal Relationships 1.34  (0.91) 0.70  (0.77)
BPDSI Subscale Score - Identity 2.76  (1.14) 1.49  (1.34)
BPDSI Subscale Score - Impulsivity 0.78  (0.62) 0.32  (0.37)
BPDSI Subscale Score - Parasuicidal Behavior 0.48  (0.62) 0.30  (0.46)
BPDSI Subscale Score - Affective Instability 4.40  (1.79) 4.48  (2.41)
BPDSI Subscale Score - Emptiness 3.96  (2.17) 2.35  (1.39)
BPDSI Subscale Score - Outbursts of Anger 1.45  (1.27) 1.53  (2.36)
BPDSI Sub. Score-Dissociation & Paranoid Ideation 1.45  (0.98) 1.14  (1.28)
6.Secondary Outcome
Title Symptom Change - BPRS
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPRS - Baseline 37.70  (5.85) 37.50  (7.09)
BPRS - 7 days of study medication 33.90  (6.15) 33.36  (7.30)
BPRS - 7 days after disc of study med 35.78  (6.57) 33.50  (7.66)
BPRS - 21 days after disc study med 35.22  (6.34) 30.50  (5.44)
7.Secondary Outcome
Title Symptom Change - Borderline Checklist
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPD Checklist - Baseline 103.60  (30.83) 96.92  (26.29)
BPD Checklist - 7 days of study med 98.10  (27.22) 88.36  (32.02)
BPD Checklist - 7 days after disc of study med 91.56  (26.74) 82.80  (37.94)
BPD Checklist - 21 days after disc study med 87.89  (24.31) 78.80  (28.01)
8.Secondary Outcome
Title Symptom Change - SCL-90-R
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
SCl-90-R - Somatization 55.80  (6.18) 50.25  (9.96)
SCL-90-R - Obsessive-Complusive 56.20  (8.48) 51.50  (9.04)
SCL-90-R - Interpersonal Sensitivity 56.50  (12.19) 51.58  (7.55)
SCL-90-R - Depression 54.40  (8.91) 49.75  (9.20)
SCL-90-R - Anxiety 52.60  (9.09) 47.17  (7.72)
SCL-90-R - Hostility 53.70  (8.54) 53.00  (7.60)
SCL-90-R - Phobic Anxiety 50.00  (8.94) 54.58  (11.05)
SCL-90-R - Paranoid Ideation 56.40  (9.75) 48.45  (7.66)
SCL-90-R - Psychoticism 52.20  (9.37) 47.67  (8.55)
SCL-90-R - Global Severity Index 55.20  (9.16) 50.00  (8.42)
SCL-90-R - Positive Symptom Total 55.90  (10.72) 49.00  (7.95)
SCL-90-R - Positive Symptom Distress Index 54.50  (7.49) 52.25  (8.92)
9.Secondary Outcome
Title Metacognitive Capacity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The IPII assessment was added to the study midway through the study therefore, the first 10 subjects did not have this assessments.
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
IIPI - Self-Reflectivity - Baseline 5.08  (1.63) 4.63  (1.70)
IIPI-Self-Reflectivity-21 days after dis study med 5.25  (1.89) 3.90  (0.42)
IIPI - Understanding Others - Baseline 3.25  (1.08) 2.88  (1.31)
IIPI-Understanding Others-21 days after dis meds 2.75  (0.50) 2.50  (1.00)
IIPI - Decentration - Baseline 0.50  (0.45) 0.38  (0.48)
IIPI-Decentration-21 days after dis meds 0.38  (0.75) 0.20  (0.45)
IIPI - Mastery - Baseline 2.67  (1.89) 3.88  (2.10)
IIPI-Mastery-21 days after dis meds 2.75  (0.50) 2.80  (1.64)
IIPI - Total - Baseline 11.50  (4.69) 11.75  (4.99)
IIPI-Total-21 days after dis meds 11.13  (2.95) 9.40  (2.43)
10.Secondary Outcome
Title Symptom Change - CGI-S
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
CGI-S - Baseline 4.30  (0.67) 4.42  (0.90)
CGI-S - 7 days of study med 4.20  (1.03) 4.09  (1.04)
CGI-S - 21 days after disc of study med 3.89  (0.93) 3.70  (0.95)
11.Secondary Outcome
Title Symptom Change - CGI-I
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
CGI-I - 7 days of study med 3.30  (1.16) 3.36  (1.29)
CGI-I - 21 days after disc of study med 3.44  (1.01) 2.80  (1.14)
12.Secondary Outcome
Title Symptom Change - BPDSI Subscales
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPDSI Subscale Score - Abandonment 0.90  (0.59) 1.27  (1.15)
BPDSI Subscale Score - Interpersonal Relationships 0.80  (0.54) 0.58  (0.53)
BPDSI Subscale Score - Identity 1.64  (1.13) 1.34  (0.85)
BPDSI Subscale Score - Impulsivity 0.66  (0.64) 0.11  (0.17)
BPDSI Subscale Score - Parasuicidal Behavior 0.37  (0.52) 0.19  (0.37)
BPDSI Subscale Score - Affective Instability 3.67  (2.43) 2.89  (1.90)
BPDSI Subscale Score - Emptiness 2.76  (1.81) 1.51  (0.91)
BPDSI Subscale Score - Outbursts of Anger 1.08  (1.20) 0.79  (0.92)
BPDSI Sub. Score-Dissociation & Paranoid Ideation 1.63  (1.26) 0.77  (0.84)
13.Secondary Outcome
Title Symptom Change - BPDSI Subscales
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
BPDSI Subscale Score - Abandonment 1.06  (0.75) 0.63  (0.67)
BPDSI Subscale Score - Interpersonal Relationships 0.84  (0.86) 0.64  (0.88)
BPDSI Subscale Score - Identity 1.92  (1.12) 0.63  (0.76)
BPDSI Subscale Score - Impulsivity 0.53  (0.58) 0.11  (0.14)
BPDSI Subscale Score - Parasuicidal Behavior 0.43  (0.38) 0.25  (0.37)
BPDSI Subscale Score - Affective Instability 3.27  (2.10) 2.96  (1.60)
BPDSI Subscale Score - Emptiness 2.94  (1.86) 1.79  (1.67)
BPDSI Subscale Score - Outbursts of Anger 0.97  (1.22) 0.62  (1.07)
BPDSI Sub. Score-Dissociation & Paranoid Ideation 1.62  (1.03) 0.56  (0.58)
14.Secondary Outcome
Title Symptom Change - SCL-90-R
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
SCl-90-R - Somatization 53.00  (10.92) 46.27  (9.18)
SCL-90-R - Obsessive-Complusive 54.30  (11.49) 47.91  (9.69)
SCL-90-R - Interpersonal Sensitivity 53.00  (10.07) 48.45  (10.05)
SCL-90-R - Depression 52.60  (9.32) 47.82  (10.05)
SCL-90-R - Anxiety 49.10  (10.08) 43.09  (9.39)
SCL-90-R - Hostility 52.80  (9.07) 52.00  (10.85)
SCL-90-R - Phobic Anxiety 49.60  (6.59) 49.55  (7.88)
SCL-90-R - Paranoid Ideation 53.80  (10.38) 47.91  (8.88)
SCL-90-R - Psychoticism 48.80  (8.16) 47.27  (10.67)
SCL-90-R - Global Severity Index 52.30  (9.89) 45.82  (9.29)
SCL-90-R - Positive Symptom Total 53.40  (11.89) 46.91  (9.69)
SCL-90-R - Positive Symptom Distress Index 54.20  (11.49) 51.91  (17.04)
15.Secondary Outcome
Title Symptom Change - SCL-90-R
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
SCl-90-R - Somatization 49.78  (15.21) 47.60  (10.70)
SCL-90-R - Obsessive-Complusive 51.33  (9.80) 44.60  (12.69)
SCL-90-R - Interpersonal Sensitivity 48.89  (10.48) 45.30  (8.79)
SCL-90-R - Depression 49.00  (9.86) 44.00  (12.44)
SCL-90-R - Anxiety 48.44  (9.25) 42.70  (10.27)
SCL-90-R - Hostility 50.11  (12.50) 48.80  (6.84)
SCL-90-R - Phobic Anxiety 46.00  (6.96) 50.10  (8.75)
SCL-90-R - Paranoid Ideation 50.33  (10.48) 46.80  (12.56)
SCL-90-R - Psychoticism 45.44  (8.50) 45.70  (13.31)
SCL-90-R - Global Severity Index 49.00  (10.30) 45.10  (12.05)
SCL-90-R - Positive Symptom Total 49.56  (11.22) 44.80  (10.40)
SCL-90-R - Positive Symptom Distress Index 51.67  (13.19) 46.60  (12.47)
Time Frame Screening through 21 days after study medication was discontinued
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description

Mifepristone 600mg once daily x 7 days

mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days

Matching placebo tablets one daily

Placebo: 3 tablets once daily for seven days

All-Cause Mortality
Mifepristone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/12 (8.33%)    
Renal and urinary disorders     
Foreign body in urethra  [1]  0/10 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
Hospitalization for a foreign body in the urethra
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mifepristone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/12 (83.33%)    
Blood and lymphatic system disorders     
Hypokalemia   2/10 (20.00%)  2 1/12 (8.33%)  1
Cardiac disorders     
Abnormal electrocardiogram   2/10 (20.00%)  2 1/12 (8.33%)  1
Eye disorders     
Blurry Vision   2/10 (20.00%)  2 0/12 (0.00%)  0
Dry Eyes   1/10 (10.00%)  1 0/12 (0.00%)  0
Gastrointestinal disorders     
Abdominal bloating   0/10 (0.00%)  0 1/12 (8.33%)  1
Abdominal Pain   1/10 (10.00%)  2 2/12 (16.67%)  4
Constipation   1/10 (10.00%)  1 0/12 (0.00%)  0
Diarrhea   1/10 (10.00%)  1 2/12 (16.67%)  2
Gastroenteritis   0/10 (0.00%)  0 1/12 (8.33%)  1
Nausea   5/10 (50.00%)  6 2/12 (16.67%)  2
General disorders     
Chills   0/10 (0.00%)  0 1/12 (8.33%)  1
Decreased Appetite   0/10 (0.00%)  0 1/12 (8.33%)  1
Decreased Concentration   0/10 (0.00%)  0 1/12 (8.33%)  2
Dizziness   1/10 (10.00%)  1 0/12 (0.00%)  0
Exhaustion   1/10 (10.00%)  1 1/12 (8.33%)  1
Hand tremor   1/10 (10.00%)  1 1/12 (8.33%)  1
Headache/migraine   3/10 (30.00%)  3 4/12 (33.33%)  4
Increased appetite   0/10 (0.00%)  0 1/12 (8.33%)  1
influenza   0/10 (0.00%)  0 1/12 (8.33%)  1
insomnia   1/10 (10.00%)  1 0/12 (0.00%)  0
Irritability   0/10 (0.00%)  0 2/12 (16.67%)  2
mouth sores   1/10 (10.00%)  1 0/12 (0.00%)  0
Sinus congestion   1/10 (10.00%)  1 0/12 (0.00%)  0
Somnolence   3/10 (30.00%)  3 0/12 (0.00%)  0
Toothache   0/10 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Upper respiratory infection   1/10 (10.00%)  1 2/12 (16.67%)  2
Musculoskeletal and connective tissue disorders     
Arthritis   0/10 (0.00%)  0 1/12 (8.33%)  1
Costochondritis   1/10 (10.00%)  1 0/12 (0.00%)  0
Fibromyalgia   1/10 (10.00%)  1 0/12 (0.00%)  0
Heaviness in legs   0/10 (0.00%)  0 1/12 (8.33%)  1
Pain   3/10 (30.00%)  3 1/12 (8.33%)  1
Pre-existing restless leg syndrome   1/10 (10.00%)  1 0/12 (0.00%)  0
Shakiness   0/10 (0.00%)  0 1/12 (8.33%)  1
Psychiatric disorders     
Anxiety   1/10 (10.00%)  1 1/12 (8.33%)  1
Exacerbation of borderline personality disorder   0/10 (0.00%)  0 2/12 (16.67%)  2
Renal and urinary disorders     
Hemorrhoids   1/10 (10.00%)  1 0/12 (0.00%)  0
Urinary tract infection   0/10 (0.00%)  0 3/12 (25.00%)  3
Reproductive system and breast disorders     
Cramping   0/10 (0.00%)  0 2/12 (16.67%)  2
Dysmenorrhea   1/10 (10.00%)  1 0/12 (0.00%)  0
lactation   0/10 (0.00%)  0 1/12 (8.33%)  1
menstural bleeding   1/10 (10.00%)  1 1/12 (8.33%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma   0/10 (0.00%)  0 1/12 (8.33%)  2
lump in throat   1/10 (10.00%)  1 0/12 (0.00%)  0
Pharyngitis   0/10 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders     
Atopic Dermatitis   0/10 (0.00%)  0 1/12 (8.33%)  1
Bug Bites   1/10 (10.00%)  1 0/12 (0.00%)  0
Dog Bite Infection   1/10 (10.00%)  1 0/12 (0.00%)  0
Ecchymosis   0/10 (0.00%)  0 1/12 (8.33%)  1
Pruritus   2/10 (20.00%)  2 0/12 (0.00%)  0
Rash   3/10 (30.00%)  3 0/12 (0.00%)  0
Rosacea   1/10 (10.00%)  1 0/12 (0.00%)  0
worsening acne   0/10 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alan Breier
Organization: IndianaU
Phone: 317-880-8495
EMail: abreier@iupui.edu
Layout table for additonal information
Responsible Party: Alan Breier, Indiana University
ClinicalTrials.gov Identifier: NCT01212588     History of Changes
Other Study ID Numbers: 1011002977
First Submitted: September 29, 2010
First Posted: September 30, 2010
Results First Submitted: January 3, 2019
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019