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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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