Phase 2
N=15
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01333098 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mifepristone (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects |
1 | — |
| PRIMARY Number of Participants With Self-reported Side Effects |
5; 3; 2 | — |
| PRIMARY Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures. |
0.93; -0.59; 1.85; -0.45; 3.00; -0.26 | — |
| SECONDARY Anxiety Symptoms |
30.80; 27.88; 22.40; 27.00; 23.0; 25.29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01333098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.