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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Memory
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated 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:
  • 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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333098

Locations
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Eric Lenze
Investigators
Principal Investigator: Eric J Lenze, MD Washington University in St. Louis School of Medicine
  More Information

No publications provided

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 26, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Washington University School of Medicine:
anxiety
geriatric
older adult
memory
cognitive
 cognition
Saint Louis
treatment
Non-dementia cognitive impairment in older adults with anxiety disorders.

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 18, 2013