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

Stanford University

Status and phase: Completed; Early Phase 1

Conditions: Depression

Treatments: Drug: Placebo; Drug: Hydrocortisone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02837432

19771

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

192 participants in 2 patient groups

Healthy

Other group

Description:

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

Treatment:

Drug: Hydrocortisone acetate

Drug: Placebo

Depression

Other group

Description:

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

Treatment:

Drug: Hydrocortisone acetate

Drug: Placebo