Study Stopped
Principal Investigator left lab before study start
Epinephrine and Cortisol in Depression
The Effects of Epinephrine and Cortisol on Emotion in Depression
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study investigates the effects of two hormones called epinephrine and cortisol on how the brain processes emotional material using functional MRI to measure brain activity. The study hopes to learn how epinephrine and cortisol affect the brain differently in depressed and non-depressed individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 6, 2021
September 1, 2021
2 years
October 30, 2019
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging
2 hours
Study Arms (4)
Healthy Arm, CORT + EPI, then PLB + EPI
ACTIVE COMPARATORHealthy participant will receive cortisol pill and epinephrine infusion
Healthy Arm, PLB + EPI, then CORT + EPI
ACTIVE COMPARATORHealthy participant will receive placebo pill and epinephrine infusion
Depression Arm, CORT + EPI, then PLB + EPI
EXPERIMENTALDepressed participant will receive cortisol pill and epinephrine infusion
Depression Arm, PLB + EPI, then CORT + EPI
EXPERIMENTALDepressed participant will receive placebo pill and epinephrine infusion
Interventions
Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Participants will receive a placebo
Eligibility Criteria
You may qualify if:
- Weight of less than 280 pounds
- HAM-D Score of greater than 7 for depression participants
You may not qualify if:
- Psychotropic medications
- Recent surgery
- Endocrine disorders
- Liver disease
- Kidney disease
- Thyroid disorder
- History of malaria
- Tuberculosis
- Osteoporosis
- Glaucoma or cataracts
- Chronic expressed infections (herpes, HIV, etc)
- History of congestive heart failure
- History of recurring seizures
- Stomach ulcers
- Comorbid psychosis
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
- SPONSOR
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 1, 2019
Study Start
December 1, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
October 6, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share