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Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders (Mifepristone)
This study has been completed.
Sponsor:
Eric Lenze
Information provided by (Responsible Party):
Eric Lenze, Washington University
ClinicalTrials.gov Identifier:
NCT01333098
First received: March 24, 2011
Last updated: March 19, 2014
Last verified: March 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Anxiety Disorders | Drug: Mifepristone | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders |
Resource links provided by NLM:
Further study details as provided by Eric Lenze, Washington University:
Primary Outcome Measures:
- Drug acceptability, as measured by self-reported side effects and number of dropouts [ Time Frame: Baseline, Week 2, Week 4 ]
- Drug tolerability, as measured by self-reported side effects and drop-out rates [ Time Frame: Baseline, Week 2, Week 4 ]
- 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:
- anxiety and depressive symptoms [ Time Frame: baseline, week 1, week 2, week 4, week 12 ]self report symptoms of anxiety, worry, depression
| Enrollment: | 16 |
| Study Start Date: | September 2012 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
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.
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01333098
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333098
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
Additional Information:
Publications:
| Responsible Party: | Eric Lenze, Professor of Psychiatry, Washington University |
| ClinicalTrials.gov Identifier: | NCT01333098 History of Changes |
| Other Study ID Numbers: |
201011836 |
| Study First Received: | March 24, 2011 |
| Last Updated: | March 19, 2014 |
Keywords provided by Eric Lenze, Washington University:
|
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 Cognition Disorders Pathologic Processes Mental 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 |
ClinicalTrials.gov processed this record on June 23, 2017