Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
| Status: | Completed |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 3/20/2019 |
| Start Date: | September 2012 |
| End Date: | April 2013 |
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.
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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