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

NCT ID: NCT01988610

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-02-28

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Open-label trial to assess the effects of Mifepristone on mood and cognition in people with a history of depression.

Group Type: EXPERIMENTAL

28 days treatment with Mifepristone.

Intervention Type: DRUG

Interventions

28 days treatment with Mifepristone.

Intervention Type: DRUG

Other Intervention Names

Korlym; RU486

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Natalie Rasgon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalie Rasgon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Psychiatry, 401 Quarry Rd

Stanford, California, United States

Countries

United States

Other Identifiers

26482

Identifier Type: -

Identifier Source: org_study_id