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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837432
• Other study ID #: 19771
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2016
• Est. completion date: November 15, 2020

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: November 15, 2020
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Hydrocortisone acetate

• Placebo

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences, 401 Quarry Road	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.		2 hours