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
This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and disabling in older adults. One particularly impairing aspect of late-life anxiety disorders is cognitive impairment: impairments in memory and executive function cause disability, impede treatment response to psychotherapy, may lead to dementia, and are not corrected by standard anti-anxiety treatments.
This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder, with well-documented safety and tolerability.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Drug: Mifepristone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||In the first week, participants were randomly assigned to mifepristone 300mg daily or placebo. In the subsequent 3 weeks, all participants received mifepristone 300mg.|
|Masking:||None (Open Label)|
|Official Title:||Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)
300mg per day, by mouth, for 21-28 days
- Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects [ Time Frame: Baseline, Week 2, Week 4 ]number of participants with dose-limiting side effects
- Number of Participants With Self-reported Side Effects [ Time Frame: 4 weeks ]
- Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures. [ Time Frame: Baseline, Week 4, Week 12 ]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.
- Anxiety Symptoms [ Time Frame: baseline, week 4, week 12 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333098
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Eric J Lenze, MD||Washington University School of Medicine|