Anxiety Disorders Clinical Trial
Official title:
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
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.
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. ;
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