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

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: 28 days treatment with Mifepristone.

• Registration Number: NCT01988610
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	28 days treatment with Mifepristone.	Open-label trial to assess the effects of Mifepristone on mood and cognition in people with a history of depression.

Primary Outcome Measures

Name	Time	Method
Cognition	3 months	Neurocognitive testing will assess changes in memory and attention

Secondary Outcome Measures

Name	Time	Method
Hamilton Score	3 months	Change in hamilton score as a measure of current mood.

Trial Locations

Locations (1)

Stanford University Psychiatry, 401 Quarry Rd; 🇺🇸 Stanford, California, United States