Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders (Mifepristone)
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| ClinicalTrials.gov Identifier: NCT01333098 |
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Recruitment Status :
Completed
First Posted : April 11, 2011
Last Update Posted : March 20, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Disorders | Drug: Mifepristone | Phase 1 Phase 2 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: mifepristone
1 week mifepristone (followed by 3 weeks open label mifepristone)
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Drug: Mifepristone
300mg per day, by mouth, for 21-28 days
Other Names:
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Placebo Comparator: placebo
1 week placebo(followed by 3 weeks open label mifepristone)
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Drug: Mifepristone
300mg per day, by mouth, for 21-28 days
Other Names:
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- 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 ]
- anxiety and depressive symptoms [ Time Frame: baseline, week 1, week 2, week 4, week 12 ]self report symptoms of anxiety, worry, depression
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333098
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Eric J Lenze, MD | Washington University School of Medicine |
Additional Information:
Publications of Results:
| 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 Key Record Dates |
| Last Update Posted: | March 20, 2014 |
| Last Verified: | March 2014 |
Keywords provided by Eric Lenze, Washington University School of Medicine:
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anxiety older adult memory cognitive |
Saint Louis treatment Non-dementia cognitive impairment in older adults with anxiety disorders. |
Additional relevant MeSH terms:
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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 |