Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

Sponsors

Lead Sponsor: Washington University School of Medicine

Source Washington University School of Medicine
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.

Overall Status Completed
Start Date 2012-09-01
Completion Date 2013-04-01
Primary Completion Date 2013-04-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects Baseline, Week 2, Week 4
Number of Participants With Self-reported Side Effects 4 weeks
Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures. Baseline, Week 4, Week 12
Secondary Outcome
Measure Time Frame
Anxiety Symptoms baseline, week 4, week 12
Enrollment 15
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mifepristone

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

Arm Group Label: mifepristone

Eligibility

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

Gender:

All

Minimum Age:

60 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Eric J Lenze, MD Principal Investigator Washington University School of Medicine
Location
Facility: Washington University School of Medicine
Location Countries

United States

Verification Date

2020-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: mifepristone

Type: Experimental

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

Acronym Mifepristone
Patient Data No
Study Design Info

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.

Primary Purpose: Treatment

Masking: None (Open Label)

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