Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mifepristone

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

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

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

Interventions

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Mifepristone

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

Intervention Type DRUG

Other Intervention Names

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Mifeprex RU-486

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes