This trial is active, not recruiting.

Condition depression
Treatments hydrocortisone acetate, placebo
Phase phase 0
Sponsor Stanford University
Start date July 2016
End date July 2020
Trial size 80 participants
Trial identifier NCT02837432, 19771


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
hydrocortisone acetate Cortef
Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
hydrocortisone acetate Cortef

Primary Outcomes

Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
time frame: 2 hours

Eligibility Criteria

Male or female participants at least 21 years old.

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 information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Stanford University.