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Completed

NCT Number: NCT01333098

Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

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.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

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

Other names: Mifeprex, RU-486

Primary outcomes

  1. Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects

    Time frame: Baseline, Week 2, Week 4

    number of participants with dose-limiting side effects

  2. Number of Participants With Self-reported Side Effects

    Time frame: 4 weeks

  3. Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures.

    Time frame: Baseline, Week 4, Week 12

    Memory composite z-score: The two memory measures were a 16-word list recall similar to the Rey auditory verbal learning test, which has been used by the Washington University Alzheimer's Disease Research Center; and two paragraphs from a set of paragraph recall tests validated as sensitive to effects of stress-level glucocorticoids. For each memory variable, a z score was computed for each participant, where z score = (participant score mean)/standard deviation. Then a single composite memory variable was created by summing up these z scores. Summed Z-scores range from -6 to 6, with scores above 0 being higher than the mean.

Secondary outcomes

  1. Anxiety Symptoms

    Time frame: baseline, week 4, week 12

    Self-report assessment of worry using Penn State Worry Questionnaire- Abbreviated, an 8-item measure (range 8-40 with high scores indicating higher levels of anxiety and worry symptoms.The average score for older adults with generalized anxiety disorder is 22, while the mean score for healthy older adults is 15.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: Mifepristone

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2011
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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