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

Early Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Hydrocortisone acetate; Drug: Placebo

• Registration Number: NCT02837432
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Primary Completion: 2019-12-13
• Study Completion: 2020-11-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy	Placebo	Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
Depression	Placebo	Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
Healthy	Hydrocortisone acetate	Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
Depression	Hydrocortisone acetate	Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order

Primary Outcome Measures

Name	Time	Method
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.	2 hours

Trial Locations

Locations (1)

Department of Psychiatry and Behavioral Sciences, 401 Quarry Road; 🇺🇸 Stanford, California, United States