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

NCT01988610 | Completed Phase 1 DMC

• 1 other identifier: 26482
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

cognition; prediabetes; mood

Outcome Measures

Primary Outcomes (1)

• Cognition

  Neurocognitive testing will assess changes in memory and attention

  3 months

Secondary Outcomes (1)

• Hamilton Score

  3 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

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.

Interventions

28 days treatment with Mifepristone. DRUG

Also known as: Korlym, RU486

Intervention Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Psychiatry, 401 Quarry Rd

Stanford, California, 94102, United States

Location

MeSH Terms

Conditions

Depression; Prediabetic State

Interventions

Therapeutics; Mifepristone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Natalie Rasgon, M.D., Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)