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Epinephrine and Cortisol in Depression

Primary Purpose

Depression

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Hydrocortisone Acetate (CORT)
Epinephrine Sulfate (EPI)
Placebo (PLB)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Healthy Arm, CORT + EPI, then PLB + EPI

    Healthy Arm, PLB + EPI, then CORT + EPI

    Depression Arm, CORT + EPI, then PLB + EPI

    Depression Arm, PLB + EPI, then CORT + EPI

    Arm Description

    Healthy participant will receive cortisol pill and epinephrine infusion

    Healthy participant will receive placebo pill and epinephrine infusion

    Depressed participant will receive cortisol pill and epinephrine infusion

    Depressed participant will receive placebo pill and epinephrine infusion

    Outcomes

    Primary Outcome Measures

    Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2019
    Last Updated
    September 29, 2021
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04148261
    Brief Title
    Epinephrine and Cortisol in Depression
    Official Title
    The Effects of Epinephrine and Cortisol on Emotion in Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal Investigator left lab before study start
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Arm, CORT + EPI, then PLB + EPI
    Arm Type
    Active Comparator
    Arm Description
    Healthy participant will receive cortisol pill and epinephrine infusion
    Arm Title
    Healthy Arm, PLB + EPI, then CORT + EPI
    Arm Type
    Active Comparator
    Arm Description
    Healthy participant will receive placebo pill and epinephrine infusion
    Arm Title
    Depression Arm, CORT + EPI, then PLB + EPI
    Arm Type
    Experimental
    Arm Description
    Depressed participant will receive cortisol pill and epinephrine infusion
    Arm Title
    Depression Arm, PLB + EPI, then CORT + EPI
    Arm Type
    Experimental
    Arm Description
    Depressed participant will receive placebo pill and epinephrine infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocortisone Acetate (CORT)
    Other Intervention Name(s)
    Cortef
    Intervention Description
    Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    Epinephrine Sulfate (EPI)
    Other Intervention Name(s)
    Adrenalin
    Intervention Description
    Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (PLB)
    Intervention Description
    Participants will receive a placebo
    Primary Outcome Measure Information:
    Title
    Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keith Sudheimer, Ph.D.
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Epinephrine and Cortisol in Depression

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