Epinephrine and Cortisol in Depression

September 29, 2021 updated by: Stanford University

The Effects of Epinephrine and Cortisol on Emotion in Depression

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight of less than 280 pounds
  • HAM-D Score of greater than 7 for depression participants

Exclusion Criteria:

  • 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
  • Current use of illicit drugs
  • Diabetes
  • Any cardiovascular disease (angina, hypovolemia, coronary artery disease, low/high blood pressure, etc)
  • Any pulmonary disease
  • Any cerebrovascular disease
  • Sulfate hypersensitivity
  • Glaucoma
  • Infection
  • Pregnancy
  • Parkinson's Disease
  • Panic Disorder
  • Over 280 pounds in weight
  • In-dwelling ferrous metals
  • Left handed
  • Abnormal hearing
  • Claustrophobic
  • Head injury with loss of consciousness
  • Active suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Arm, CORT + EPI, then PLB + EPI
Healthy participant will receive cortisol pill and epinephrine infusion
Drug: Hydrocortisone Acetate (CORT)
Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg
Other Names:
  • Cortef
Drug: Epinephrine Sulfate (EPI)
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Other Names:
  • Adrenalin
Active Comparator: Healthy Arm, PLB + EPI, then CORT + EPI
Healthy participant will receive placebo pill and epinephrine infusion
Drug: Epinephrine Sulfate (EPI)
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Other Names:
  • Adrenalin
Drug: Placebo (PLB)
Participants will receive a placebo
Experimental: Depression Arm, CORT + EPI, then PLB + EPI
Depressed participant will receive cortisol pill and epinephrine infusion
Drug: Hydrocortisone Acetate (CORT)
Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg
Other Names:
  • Cortef
Drug: Epinephrine Sulfate (EPI)
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Other Names:
  • Adrenalin
Experimental: Depression Arm, PLB + EPI, then CORT + EPI
Depressed participant will receive placebo pill and epinephrine infusion
Drug: Epinephrine Sulfate (EPI)
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Other Names:
  • Adrenalin
Drug: Placebo (PLB)
Participants will receive a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Keith Sudheimer, Ph.D., Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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