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Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders (Mifepristone)

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ClinicalTrials.gov Identifier: NCT01333098
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : March 18, 2019
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anxiety Disorders
Intervention Drug: Mifepristone
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone
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1 week mifepristone or placebo, followed by 3 weeks open label mifepristone

Mifepristone: 300mg per day, by mouth, for 21-28 days

Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Arm/Group Title Mifepristone
Hide Arm/Group Description

1 week mifepristone or placebo followed by 3 weeks open label mifepristone

Mifepristone: 300mg per day, by mouth, for 21-28 days

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  20.0%
>=65 years
12
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
73.1  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
11
  73.3%
Male
4
  26.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects
Hide Description number of participants with dose-limiting side effects
Time Frame Baseline, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
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1 week mifepristone or placebo, followed by 3 weeks open label mifepristone

Mifepristone: 300mg per day, by mouth, for 21-28 days

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.7%
2.Primary Outcome
Title Number of Participants With Self-reported Side Effects
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
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1 week mifepristone or placebo, followed by 3 weeks open label mifepristone

Mifepristone: 300mg per day, by mouth, for 21-28 days

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants with reported side effects
dizziness 5
fatigue 3
nausea 2
3.Primary Outcome
Title Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures.
Hide Description Memory composite z-score: The two memory measures were a 16-word list recall similar to the Rey auditory verbal learning test, which has been used by the Washington University Alzheimer's Disease Research Center; and two paragraphs from a set of paragraph recall tests validated as sensitive to effects of stress-level glucocorticoids. For each memory variable, a z score was computed for each participant, where z score = (participant score mean)/standard deviation. Then a single composite memory variable was created by summing up these z scores. Summed Z-scores range from -6 to 6, with scores above 0 being higher than the mean.
Time Frame Baseline, Week 4, Week 12
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Baseline Cortisol Without High Baseline Corisol
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baseline peak cortisol >6 ng/ml
baseline peak cortisol <6 ng/ml
Overall Number of Participants Analyzed 5 8
Mean (Standard Error)
Unit of Measure: z-score
Baseline 0.93  (1.58) -0.59  (1.24)
Week 4 1.85  (1.97) -0.45  (1.34)
Week 12 3.00  (2.20) -0.26  (1.42)
4.Secondary Outcome
Title Anxiety Symptoms
Hide Description Self-report assessment of worry using Penn State Worry Questionnaire- Abbreviated, an 8-item measure (range 8-40 with high scores indicating higher levels of anxiety and worry symptoms.The average score for older adults with generalized anxiety disorder is 22, while the mean score for healthy older adults is 15.
Time Frame baseline, week 4, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Baseline Cortisol Without High Baseline Corisol
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baseline peak cortisol >6 ng/ml
baseline peak cortisol <6 ng/ml
Overall Number of Participants Analyzed 5 8
Mean (Standard Error)
Unit of Measure: Scores on a scale
Baseline 30.80  (4.27) 27.88  (1.85)
Week 4 22.40  (6.09) 27.00  (1.51)
Week 12 23.0  (6.02) 25.29  (2.39)
Time Frame Adverse event data was collected during the course of each participant's 12 week participation in the study which took place during a 4 month period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone
Hide Arm/Group Description

1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)

Mifepristone: 300mg per day, by mouth, for 21-28 days

All-Cause Mortality
Mifepristone
Affected / at Risk (%)
Total   0/15 (0.00%)    
Hide Serious Adverse Events
Mifepristone
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mifepristone
Affected / at Risk (%) # Events
Total   5/15 (33.33%)    
Blood and lymphatic system disorders   
Neutropenia   1/15 (6.67%)  1
Hypokalemia   2/15 (13.33%)  2
Cardiac disorders   
Worsening of pre-existing orthostatic hypotension   1/15 (6.67%)  1
Endocrine disorders   
Reduced T4   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
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: Eric Lenze, MD
Organization: Washington University School of Medicine
Phone: 314-362-5154
EMail: lenzee@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01333098    
Other Study ID Numbers: 201011836
First Submitted: March 24, 2011
First Posted: April 11, 2011
Results First Submitted: April 5, 2018
Results First Posted: March 18, 2019
Last Update Posted: August 18, 2020