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Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals

Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01988610
Enrollment
23
Registered
2013-11-20
Start date
2013-10-31
Completion date
2017-02-28
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

cognition, prediabetes, mood

Brief summary

The purpose of this study is to study the effect of cortisol,a stress hormone in the body, on memory and attention in people with a history of depression, but who are not in the midst of a current depressive episode. Cortisol may affect parts of the brain associated with memory and attention directly. It may also indirectly affect the brain by controlling how much insulin the body makes. Insulin is thought to impact cognition by changing the amount of sugar available in certain parts of the brain. The investigators are studying this question by giving patients a medication, called Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare results from several groups of people, including differences between men and women, and between those with and without insulin resistance.

Detailed description

The specific aims of this study are threefold: 1. To evaluate the association between glucose utilization and neuropsychological performance on tests of verbal memory and attention among patients with a history of depression, but who are euthymic, at baseline; 2. To evaluate changes in neuropsychological test performance among patients with a history of depression and who have insulin resistance who are treated with open-label mifepristone and, 3. To explore interactions between changes in patients' glucose tolerance profiles and changes in verbal memory and attention. An exploratory aim is to explore the interaction of changes in cortisol awakening response and changes in verbal memory and attention within subjects with and without IGT, as well as the potential mediating effects of gender.

Interventions

DRUG28 days treatment with Mifepristone.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Ages 50-70 * History of depression, not currently depressed.

Exclusion criteria

* History of type 1 or type 2 diabetes. * Use of a medication that interacts with Mifepristone.

Design outcomes

Primary

MeasureTime frameDescription
Cognition3 monthsNeurocognitive testing will assess changes in memory and attention

Secondary

MeasureTime frameDescription
Hamilton Score3 monthsChange in hamilton score as a measure of current mood.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026