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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 : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:

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

Detailed Description:
Currently, no treatment exists to address cognitive impairment in late-life anxiety disorders. In this study, fifteen patients aged 60+ with an anxiety disorder (current or in partial remission) and subjective and/or objective evidence of cognitive impairment will receive treatment with mifepristone. At the baseline visit participants will be randomized to receive either mifepristone 300mg or a placebo daily for 7 days. Participants will be reassessed after 7 days (week 1 visit) of receiving study medication (mifepristone or placebo). At that time all participants will be provided mifepristone 300mg daily for the remaining 3 weeks of study treatment. The primary outcome measure will be neurocognition, as assessed by a battery of neuropsychological measures focusing on immediate and delayed memory and executive function (administered at baseline, week 1, week 4, and week 12). Saliva samples for cortisol measurement will be collected immediately following the baseline visit and week 4 visit. Secondary outcomes will be self-reported anxiety and depressive symptoms.

Study Design
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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: mifepristone
1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)
 Drug: Mifepristone
300mg per day, by mouth, for 21-28 days
Other Names:
  • Mifeprex
  • RU-486


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Number of Participants With Self-reported Side Effects [ Time Frame: 4 weeks ]
  3. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 65 and older
  • Non-demented by clinical evaluation
  • Current or partially remitted generalized anxiety disorder or panic disorder
  • Currently taking antidepressant treatment with stable dose for at least 8 weeks
  • Memory impairment

Exclusion Criteria:

  • Mild to severe dementia
  • Diabetes
  • Current alcohol or substance abuse
  • Current or lifetime psychotic symptoms, bipolar disorder, or eating disorder
  • Untreated endocrinologic disease
  • Lifetime Cushing's or Addison's disease
  • Current cancer
  • History of metastatic cancer
  • Current use of systemic corticosteroids
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
More Information
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Additional Information:
2012  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01333098     History of Changes
Other Study ID Numbers: 201011836
First Posted: April 11, 2011    Key Record Dates
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Washington University School of Medicine:
anxiety
older adult
memory
cognitive
 Saint Louis
treatment
cognitive impariment
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Cognitive Dysfunction
Pathologic Processes
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents