Back to resultsEffects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
Primary Purpose
Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
28 days treatment with Mifepristone.
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring cognition, prediabetes, mood
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.
Sites / Locations
- Stanford University Psychiatry, 401 Quarry Rd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
Open-label trial to assess the effects of Mifepristone on mood and cognition in people with a history of depression.
Outcomes
Primary Outcome Measures
Cognition
Neurocognitive testing will assess changes in memory and attention
Secondary Outcome Measures
Hamilton Score
Change in hamilton score as a measure of current mood.
Full Information
NCT ID
NCT01988610
First Posted
November 13, 2013
Last Updated
January 23, 2018
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT01988610
Brief Title
Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
Official Title
Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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;
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,
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
cognition, prediabetes, mood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Open-label trial to assess the effects of Mifepristone on mood and cognition in people with a history of depression.
Intervention Type
Drug
Intervention Name(s)
28 days treatment with Mifepristone.
Other Intervention Name(s)
Korlym, RU486
Primary Outcome Measure Information:
Title
Cognition
Description
Neurocognitive testing will assess changes in memory and attention
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hamilton Score
Description
Change in hamilton score as a measure of current mood.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Rasgon, M.D., Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Psychiatry, 401 Quarry Rd
City
Stanford
State/Province
California
ZIP/Postal Code
94102
Country
United States
12. IPD Sharing Statement
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Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
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