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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Psychiatry and Behavioral Sciences, 401 Quarry Road

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone Acetate

Drug

Other names: Cortef

Placebo

Drug

Primary outcomes

Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.

Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Jul 19, 2016
Registry last updated: Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed