Epinephrine and Cortisol in Depression

Sponsor
Stanford University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04148261
Collaborator
(none)
0
4
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydrocortisone Acetate (CORT)
  • Drug: Epinephrine Sulfate (EPI)
  • Drug: Placebo (PLB)
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Effects of Epinephrine and Cortisol on Emotion in Depression
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging [2 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Stanford University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT04148261
    Other Study ID Numbers:
    • 53325
    First Posted:
    Nov 1, 2019
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021