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Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone

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: NCT01739335
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Stress Disorders, Post-Traumatic
Interventions Drug: Mifepristone Oral Tablet [Korlym]
Drug: Placebo Oral Tablet
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description

600 mg/day mifepristone for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Placebo (sugar pill) for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Period Title: Overall Study
Started 41 40
Completed 34 35
Not Completed 7 5
Reason Not Completed
Lost to Follow-up             7             4
Ineligible patient randomized             0             1
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill Total
Hide Arm/Group Description

600 mg/day mifepristone for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Placebo (sugar pill) for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Total of all reporting groups
Overall Number of Baseline Participants 41 39 80
Hide Baseline Analysis Population Description
The baseline comparison is based on 80 randomized patients who satisfied all study entry criteria and received at least one dose of study medication. The one subject (placebo group) who was found to be ineligible after randomization and was terminated in study dosing phase was not included.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 41 participants 39 participants 80 participants
43
(33 to 53)
37
(30 to 56)
40
(31 to 55.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
41
 100.0%
39
 100.0%
80
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
Hispanic or Latino
12
  29.3%
14
  35.9%
26
  32.5%
Not Hispanic or Latino
29
  70.7%
25
  64.1%
54
  67.5%
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 41 participants 39 participants 80 participants
American Indian or Alaska Native
1
   2.4%
0
   0.0%
1
   1.3%
Asian
1
   2.4%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.6%
1
   1.3%
Black or African American
14
  34.1%
11
  28.2%
25
  31.3%
White
20
  48.8%
26
  66.7%
46
  57.5%
More than one race
5
  12.2%
1
   2.6%
6
   7.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Clinical Responders at 4-week Follow-up
Hide Description A clinical responder at 4-week is defined as a participant who achieves a 30% or greater reduction in CAPS total score (past week symptom status) from baseline to 4-week follow-up. The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score (ranges 0 - 136) is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). The higher is the CAPS total score, the worse is the PTSD symptom. Higher percentage of responders indicate a better drug effect in treating PTSD symptoms.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week CAPS assessment were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:

600 mg/day mifepristone for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Placebo (sugar pill) for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Overall Number of Participants Analyzed 39 38
Measure Type: Count of Participants
Unit of Measure: Participants
≥ 30% Reduction in CAPS Total Score
15
  38.5%
12
  31.6%
< 30% Reduction in CAPS Total Score
24
  61.5%
26
  68.4%
2.Secondary Outcome
Title Percentage of Clinical Responders at 12-week Follow-up (End of Study)
Hide Description A clinical responder at 12-week is defined as a participant who achieves a 30% or greater reduction in CAPS total score (past week symptom status) from baseline to 12-week follow-up. The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score (ranges 0 - 136) is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). The higher is the CAPS total score, the worse is the PTSD symptom. Higher percentage of responders indicate a better drug effect in treating PTSD symptoms.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 12-week CAPS assessment were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:

600 mg/day mifepristone for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Placebo (sugar pill) for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Overall Number of Participants Analyzed 32 35
Measure Type: Count of Participants
Unit of Measure: Participants
≥ 30% Reduction in CAPS Total Score
10
  31.3%
14
  40.0%
< 30% Reduction in CAPS Total Score
22
  68.8%
21
  60.0%
3.Secondary Outcome
Title Change in CAPS Total Score From Baseline to 4-week and 12-week
Hide Description The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score ranges 0 to 136, which is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). A higher CAPS total score indicates worse PTSD symptoms. A positive change score indicates an increased CAPS total score (i.e., worse PTSD symptoms) at 4-week (12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame baseline to 4-week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% Confidence Interval (CI) reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:

600 mg/day mifepristone for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Placebo (sugar pill) for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-13.96
(-19.61 to -8.31)
-15.83
(-21.57 to -10.08)
Change Score from Baseline to 12-week
-15.15
(-22.34 to -7.96)
-18.06
(-25.16 to -10.96)
4.Other Pre-specified Outcome
Title Change in CAPS Intrusive Symptom Scores From Baseline to 4-Week and 12-Week
Hide Description The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its intrusive symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the intrusive/re-experiencing symptom subcategory. A higher intrusive symptom score indicates worse PTSD symptoms. A positive change score indicates an increased intrusive symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame baseline to 4-Week and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-4.27
(-6.89 to -1.64)
-5.49
(-8.17 to -2.82)
Change Score from Baseline to 12-week
-4.77
(-7.91 to -1.63)
-7.78
(-10.86 to -4.70)
5.Other Pre-specified Outcome
Title Change in CAPS Avoidance Symptom Scores From Baseline to 4-Week and 12-Week
Hide Description

The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its avoidance symptom subscale (ranges 0 - 56) is the sum of 7 PTSD symptoms (each ranges 0 - 8) in the avoidance/emotional numbing symptom subcategory. A higher avoidance symptom score indicates worse PTSD symptoms. A positive change score indicates an increased avoidance symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.

The higher is the avoidance/emotional numbing PTSD subscale score, the worse is the PTSD symptom.

Time Frame baseline to 4-Week and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone 600 mg/Day Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-6.24
(-9.24 to -3.24)
-6.81
(-9.86 to -3.76)
Change Score from Baseline to 12-week
-6.30
(-9.99 to -2.60)
-6.22
(-9.87 to -2.57)
6.Other Pre-specified Outcome
Title Change in CAPS Hyperarousal Symptom Scores From Baseline to 4-Week and 12-Week
Hide Description The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its hyperarousal symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the hyperarousal symptom subcategory. A higher hyperarousal symptom score indicates worse PTSD symptoms. A positive change score indicates an increased hyperarousal symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame baseline to 4-Week and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-3.35
(-5.16 to -1.53)
-3.49
(-5.33 to -1.64)
Change Score from Baseline to 12-week
-3.22
(-5.37 to -1.08)
-4.15
(-6.24 to -2.05)
7.Other Pre-specified Outcome
Title Change in Depression (Measured by the BDI Total Score) From Baseline to 4-Week and 12-Week
Hide Description The Beck Depression Inventory (BDI) total score (ranges 0-63) is the sum of 21 items (each item rated on a 4-point scale of 0 to 3) relating to symptoms of depression, cognitions, and physical symptoms. The BDI total score measures the overall severity of depression. The higher the BDI total score, the more severe the depression. A positive change score indicates an increased BDI total score (i.e., more severe depression) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame baseline to 4-Week and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-3.50
(-6.20 to -0.79)
-4.52
(-7.29 to -1.75)
Change Score from Baseline to 12-week
-2.25
(-5.34 to 0.83)
-5.07
(-8.19 to -1.96)
8.Other Pre-specified Outcome
Title Changes in PTSD Symptom Severity (Measured by the Stressful Life Total Score From the PTSD Checklist) From Baseline to 4-Week and 12-Week
Hide Description Stressful life total score (ranges 17-85) is the sum of the severity ratings of the 17 PTSD-related symptoms (each symptom is rated on a 5-point scale of 1=not at all to 5=extremely) over the past week. It evaluates the extent to which responders have been "bothered" by the symptoms of PTSD. The higher stressful life score indicates more stressful life events. A positive change score indicates an increased stressful life total score (i.e., more stressful life events) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame baseline to 4-Week and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-6.84
(-9.90 to -3.78)
-8.65
(-11.80 to -5.49)
Change Score from Baseline to 12-week
-6.84
(-10.54 to -3.14)
-8.12
(-11.90 to -4.34)
9.Other Pre-specified Outcome
Title Change in Sleep Quality (Measured by the PSQI Total Score) From Baseline to 4-Week and 12-Week
Hide Description The Pittsburgh Sleep Quality Index (PSQI) assesses self-report sleep quality and disturbances. Nineteen individual items generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. Each component is scored from 0=better to 3=worse. The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased PSQI total score (i.e., worse sleep quality) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame baseline to 4-Week and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-1.63
(-2.67 to -0.59)
-1.27
(-2.34 to -0.21)
Change Score from Baseline to 12-week
-0.86
(-2.10 to 0.40)
-2.04
(-3.29 to -0.79)
10.Other Pre-specified Outcome
Title Change in Anger Level (Measured by the STAXI Total Score) From Baseline to 4-Week and 12-Week
Hide Description The State-Trait Anger Expression Inventory (STAXI) total score is the sum of 10 items assessing intensity of anger as an emotional state (State Anger) and the disposition to experience angry feelings as a personality trait (Trait Anger). Each item consists of a 4-point scale (1=not at all, 4=very much) that assess intensity of anger at a particular moment and the frequency of anger experience, expression and control. The STAXI total score ranges from 10 to 40, with a higher score indicating a higher intensity of anger.The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased STAXI total score (i.e., higher intensity of anger) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.
Time Frame Baseline to 4-week and 12-week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change Score from Baseline to 4-week
-0.61
(-2.78 to 1.56)
-1.83
(-4.05 to 0.40)
Change Score from Baseline to 12-week
-1.73
(-3.85 to 0.39)
-3.20
(-5.32 to -1.08)
11.Other Pre-specified Outcome
Title Change in Plasma Cortisol From Baseline to 1-Week
Hide Description Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates increased cortisol level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.
Time Frame Baseline to 1-week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 1-week blood collection on cortisol were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 38
Median (Inter-Quartile Range)
Unit of Measure: ug/dl
22.3
(3.3 to 33.2)
-0.9
(-3.4 to 3.6)
12.Other Pre-specified Outcome
Title Change in Plasma Cortisol From Baseline to 4-Week
Hide Description Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased cortisol level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.
Time Frame Baseline to 4-week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week blood collection on cortisol were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 38 35
Median (Inter-Quartile Range)
Unit of Measure: ug/dl
-0.6
(-7.0 to 3.1)
-0.4
(-2.4 to 3.4)
13.Other Pre-specified Outcome
Title Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 1-week
Hide Description Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.
Time Frame baseline to 1-week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 1-week blood collection on ACTH were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 41 38
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
28.8
(7.9 to 63.7)
-0.5
(-5.0 to 5.4)
14.Other Pre-specified Outcome
Title Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 4-week
Hide Description Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.
Time Frame Baseline to 4-week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week blood collection on ACTH were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description:
600 mg/day mifepristone for one week
Placebo (sugar pill) for one week
Overall Number of Participants Analyzed 38 35
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.8
(-7.3 to 2.6)
1.5
(-5.5 to 6.2)
Time Frame Participants were enrolled for 3 months. Adverse Events (AE) and Serious Adverse Events (SAE) information were collected from randomization to study medication/placebo until 12 week follow-up and/or participant termination (whichever occurred first). If a participant experienced more than 1 of a given AE, the participant was counted only once for that AE. If a participant experienced more than one AE in a system organ class (SOC), the participant was counted only once in that SOC.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone (600 mg/Day) Sugar Pill
Hide Arm/Group Description

600 mg/day mifepristone for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

Placebo (sugar pill) for one week

Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week

All-Cause Mortality
Mifepristone (600 mg/Day) Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Mifepristone (600 mg/Day) Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/41 (2.44%)      0/40 (0.00%)    
Social circumstances     
Social stay hospitalization * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
[1]
This participant developed homicidal ideation in the setting of family stress and homelessness, which resulted in psychiatric hospitalization (preferred term: Social stay hospitalization). This event was not related to the study drug.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mifepristone (600 mg/Day) Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/41 (51.22%)      15/40 (37.50%)    
Cardiac disorders     
Sinus tachycardia * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Endocrine disorders     
Hyperthyroidism * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Gastrointestinal disorders     
Abdominal Discomfort * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Diarrhea * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Dry Mouth * 1  2/41 (4.88%)  2 0/40 (0.00%)  0
Gastrointestinal Pain * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Nausea * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
General disorders     
Energy Increased * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Fatigue * 1  3/41 (7.32%)  3 2/40 (5.00%)  2
Pain * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications     
Laceration * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Road Traffic Accident * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Investigations     
Blood thyroid stimulating hormone increase * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Electrocardiogram Prolonged QT interval * 1  1/41 (2.44%)  2 2/40 (5.00%)  2
Glomerular Filtration Rate Decrease * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Liver function test increased * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Platelet Count Decreased * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Urine analysis abnormal * 1 [1]  0/41 (0.00%)  0 1/40 (2.50%)  1
Metabolism and nutrition disorders     
Hyperkalemia * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Hypokalemia * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Tendonitis * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Nervous system disorders     
Dizziness * 1  2/41 (4.88%)  2 0/40 (0.00%)  0
Exertional headache * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Headache * 1  2/41 (4.88%)  2 3/40 (7.50%)  3
Somnolence * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Psychiatric disorders     
Anger * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Depressed Mood * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Renal and urinary disorders     
Nocturia * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Contact Dermatitis * 1 [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Eczema * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Hyperhidrosis * 1  0/41 (0.00%)  0 1/40 (2.50%)  1
Miliaria * 1  1/41 (2.44%)  1 0/40 (0.00%)  0
Pruritis * 1  2/41 (4.88%)  2 0/40 (0.00%)  0
Rash * 1 [2]  2/41 (4.88%)  2 3/40 (7.50%)  3
Rash pruritic * 1  1/41 (2.44%)  1 1/40 (2.50%)  1
Surgical and medical procedures     
Sympathectomy * 1 [1]  0/41 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders     
Hypertension * 1 [3]  2/41 (4.88%)  2 0/40 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
[1]
not related to study drug
[2]
1 rash (mifepristone) and 1 rash (placebo) were not related to study drug
[3]
1 hypertension (mifepristone) was not related to study drug
The study only look at a low dose of mifepristone (600 mg /day) for a short period (7 days). A higher dose of mifepristone (900 mg, 1200mg and etc.) haven't been studied in this trial.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julia Golier; Chief of Psychiatry
Organization: Bronx VA Medical Center
Phone: 718-584-9000 ext 6587
EMail: julia.golier@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01739335    
Obsolete Identifiers: NCT01946685
Other Study ID Numbers: MHBA-04-11S
First Submitted: November 15, 2012
First Posted: December 3, 2012
Results First Submitted: October 6, 2017
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018