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

October 14, 2021 updated by: Keith Sudheimer, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Department of Psychiatry and Behavioral Sciences, 401 Quarry Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy
Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
Drug: Placebo
Drug: Hydrocortisone acetate
Other Names:
  • Cortef
Other: Depression
Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
Drug: Placebo
Drug: Hydrocortisone acetate
Other Names:
  • Cortef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19771

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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