Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE April 11, 2011
Results First Submitted Date  ICMJE April 5, 2018
Results First Posted Date  ICMJE March 18, 2019
Last Update Posted Date August 18, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2011)
  • Drug acceptability, as measured by self-reported side effects and number of dropouts [ Time Frame: Baseline, Week 2, Week 4 ]
  • Drug tolerability, as measured by self-reported side effects and drop-out rates [ Time Frame: Baseline, Week 2, Week 4 ]
  • Cognitive changes over time, as measured by within-subjects comparison of neuropsychological measures. [ Time Frame: Baseline, Week 4 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
Official Title  ICMJE Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE Drug: Mifepristone
300mg per day, by mouth, for 21-28 days
Other Names:
  • Mifeprex
  • RU-486
Study Arms  ICMJE Experimental: mifepristone
1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)
Intervention: Drug: Mifepristone
Publications * Lenze EJ, Hershey T, Newcomer JW, Karp JF, Blumberger D, Anger J, Doré P, Dixon D. Antiglucocorticoid therapy for older adults with anxiety and co-occurring cognitive dysfunction: results from a pilot study with mifepristone. Int J Geriatr Psychiatry. 2014 Sep;29(9):962-9. doi: 10.1002/gps.4085. Epub 2014 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2011)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01333098
Other Study ID Numbers  ICMJE 201011836
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP