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The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02837432
Collaborator
(none)
192
Enrollment
1
Location
2
Arms
52.5
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This project investigates if the subgenual cingulate cortex has become insensitive to cortisol in patients with depression and tests for variants of the cortisol receptor genes that could predispose individuals to develop cortisol insensitivity.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydrocortisone acetate
  • Drug: Placebo
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Dec 13, 2019
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Healthy

Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order

Drug: Hydrocortisone acetate
Other Names:
  • Cortef

    • Drug: Placebo
    Other: Depression

    Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order

    Drug: Hydrocortisone acetate
    Other Names:
  • Cortef

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging. [2 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    https://redcap.stanford.edu/surveys/?s=3F7WCENPND

    Inclusion Criteria:

    • Healthy Participants must have no Axis 1 mental disorder

    • Participants with depression must meet minimum severity levels (Hamilton >7)

    • All participants must weight less than 280 pounds for the purposes of MRI scanning

    Exclusion Criteria:

    In order to protect against risk associated with taking Hydrocortisone, all participants must not have any of the following:

    • Psychotropic medications

    • Recent surgery

    • Endocrine disorders

    • Liver disease

    • Kidney disease

    • Thyroid disorder

    • History of malaria

    • Tuberculosis

    • Osteoporosis

    • Glaucoma/cataracts

    • Chronic expressed infections (herpes --including ocular herpes, HIV, etc.)

    • History of congestive heart failure

    • History of recurring seizures

    • Stomach Ulcers

    • Comorbid psychosis

    • Current use of illicit drugs

    • High Blood pressure

    In order to protect against risks associated with MRI scanning participants must not be/have any of the following:

    • 280 lbs

    • In-dwelling ferrous metals

    • Left Handed

    • Abnormal Hearing

    • Claustrophobic

    • Head injury with loss of consciousness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry and Behavioral Sciences, 401 Quarry Road Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Keith Sudheimer, Ph.D., Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keith Sudheimer, Clinical Assistant Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02837432
    Other Study ID Numbers:
    • 19771
    First Posted:
    Jul 19, 2016
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Keith Sudheimer, Clinical Assistant Professor, Stanford University
    Depression
    Cortisol
    Sadness
    Genetics
    Stress
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Hydrocortisone
    Hydrocortisone 17-butyrate 21-propionate
    Hydrocortisone acetate
    Hydrocortisone hemisuccinate

    Study Results

    No Results Posted as of Oct 22, 2021