Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
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|ClinicalTrials.gov Identifier: NCT01988610|
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: 28 days treatment with Mifepristone.||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: Intervention Group
Open-label trial to assess the effects of Mifepristone on mood and cognition in people with a history of depression.
Drug: 28 days treatment with Mifepristone.
- Cognition [ Time Frame: 3 months ]Neurocognitive testing will assess changes in memory and attention
- Hamilton Score [ Time Frame: 3 months ]Change in hamilton score as a measure of current mood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988610
|United States, California|
|Stanford University Psychiatry, 401 Quarry Rd|
|Stanford, California, United States, 94102|
|Principal Investigator:||Natalie Rasgon, M.D., Ph.D.||Stanford University|