Epinephrine and Cortisol in Depression

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• Status: Withdrawn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: Depression
• Intervention / Treatment: Drug: Hydrocortisone Acetate (CORT); Drug: Epinephrine Sulfate (EPI); Drug: Placebo (PLB)

• Study Type: Interventional
• Phase: Early Phase 1

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	2 hours

Collaborators and Investigators

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

Study record dates

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: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
• 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