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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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ClinicalTrials.gov Identifier: NCT01988610
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Natalie Rasgon, 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.


Condition or disease Intervention/treatment Phase
Depression Drug: 28 days treatment with Mifepristone. Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Korlym
  • RU486




Primary Outcome Measures :
  1. Cognition [ Time Frame: 3 months ]
    Neurocognitive testing will assess changes in memory and attention


Secondary Outcome Measures :
  1. Hamilton Score [ Time Frame: 3 months ]
    Change in hamilton score as a measure of current mood.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University Psychiatry, 401 Quarry Rd
Stanford, California, United States, 94102
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Natalie Rasgon, M.D., Ph.D. Stanford University
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Responsible Party: Natalie Rasgon, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01988610    
Other Study ID Numbers: 26482
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Keywords provided by Natalie Rasgon, Stanford University:
cognition
prediabetes
mood
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents