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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders	Drug: Mifepristone	Phase 1; Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
Study Start Date :	September 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: mifepristone; 1 week mifepristone (followed by 3 weeks open label mifepristone)	Drug: Mifepristone; 300mg per day, by mouth, for 21-28 days; Other Names: Mifeprex; RU-486
Placebo Comparator: placebo; 1 week placebo(followed by 3 weeks open label mifepristone)	Drug: Mifepristone; 300mg per day, by mouth, for 21-28 days; Other Names: Mifeprex; RU-486

Outcome Measures

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Primary Outcome Measures :

1. Drug acceptability, as measured by self-reported side effects and number of dropouts [ Time Frame: Baseline, Week 2, Week 4 ]
2. Drug tolerability, as measured by self-reported side effects and drop-out rates [ Time Frame: Baseline, Week 2, Week 4 ]
3. Cognitive changes over time, as measured by between group and within-subjects comparison of neuropsychological measures. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

Secondary Outcome Measures :

1. anxiety and depressive symptoms [ Time Frame: baseline, week 1, week 2, week 4, week 12 ]
   self report symptoms of anxiety, worry, depression

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Eric Lenze

Investigators

Principal Investigator:	Eric J Lenze, MD	Washington University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

2012 

Publications of Results:

Lenze EJ, Hershey T, Newcomer JW, Karp JF, Blumberger D, Anger J, Doré P, Dixon D. Antiglucocorticoid therapy for older adults with anxiety and co-occurring cognitive dysfunction: results from a pilot study with mifepristone. Int J Geriatr Psychiatry. 2014 Sep;29(9):962-9. doi: 10.1002/gps.4085. Epub 2014 Mar 14.

Responsible Party:	Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01333098 History of Changes
Other Study ID Numbers:	201011836
First Posted:	April 11, 2011
Last Update Posted:	March 20, 2014
Last Verified:	March 2014

Keywords provided by Eric Lenze, Washington University School of Medicine:

anxiety; older adult; memory; cognitive	Saint Louis; treatment; Non-dementia cognitive impairment in older adults with anxiety disorders.

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Cognitive Dysfunction; Pathologic Processes; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Mifepristone; Abortifacient Agents, Steroidal; Abortifacient Agents; Reproductive Control Agents	Physiological Effects of Drugs; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Luteolytic Agents; Menstruation-Inducing Agents