The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
1 other identifier
interventional
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 depression
Started Jul 2016
Longer than P75 for early_phase_1 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2020
CompletedOctober 22, 2021
October 1, 2021
3.5 years
July 15, 2016
October 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
2 hours
Study Arms (2)
Healthy
OTHERHealthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
Depression
OTHERIndividuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Behavioral Sciences, 401 Quarry Road
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Sudheimer, Ph.D.
Stanford University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
July 15, 2016
First Posted
July 19, 2016
Study Start
July 1, 2016
Primary Completion
December 13, 2019
Study Completion
November 15, 2020
Last Updated
October 22, 2021
Record last verified: 2021-10