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Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders (Mifepristone)

This study has been completed.
Sponsor:
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

March 24, 2011
March 19, 2014
September 2012
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01333098 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety Disorders
Drug: Mifepristone
300mg per day, by mouth, for 21-28 days
Other Names:
  • Mifeprex
  • RU-486
  • 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
Lenze EJ, Hershey T, Newcomer JW, Karp JF, Blumberger D, Anger J, Dore P, Dixon D: Antiglucocorticoid therapy for older adults with anxiety and co-occurring cognitive dysfunction: results from a pilot study with mifepristone. International Journal of Geriatric Psychiatry, PMCID: PMC Journal - In Process

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333098
201011836
No
Eric Lenze, Washington University
Eric Lenze
Not Provided
Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
Washington University School of Medicine
March 2014

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