Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eric Lenze, Washington University

ClinicalTrials.gov Identifier:

NCT01333098

First received: March 24, 2011

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2011

Last Updated Date

March 26, 2013

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Drug acceptability, as measured by self-reported side effects and number of dropouts [ Time Frame: Baseline, Week 2, Week 4 ] [ Designated as safety issue: Yes ]
Drug tolerability, as measured by self-reported side effects and drop-out rates [ Time Frame: Baseline, Week 2, Week 4 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01333098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

anxiety and depressive symptoms [ Time Frame: baseline, week 1, week 2, week 4, week 12 ] [ Designated as safety issue: No ]

self report symptoms of anxiety, worry, depression

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Anxiety Disorders

Intervention ^ICMJE

Drug: Mifepristone

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

Other Names:

Mifeprex
RU-486

Study Arm (s)

Experimental: mifepristone
1 week mifepristone (followed by 3 weeks open label mifepristone)

Intervention: Drug: Mifepristone
Placebo Comparator: placebo
1 week placebo(followed by 3 weeks open label mifepristone)

Intervention: Drug: Mifepristone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01333098

Other Study ID Numbers ^ICMJE

201011836

Has Data Monitoring Committee

Responsible Party

Eric Lenze, Washington University

Study Sponsor ^ICMJE

Eric Lenze

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eric J Lenze, MD

Washington University in St. Louis School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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