Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders (Mifepristone)

The Washington University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Anxiety Disorders

Treatments: Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT01333098

201011836

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

mifepristone

Experimental group

Description:

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

Treatment:

Drug: Mifepristone