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WithdrawnNCT04148261Updated Oct 6, 2021

Epinephrine and Cortisol in Depression

An Early Phase 1 interventional study of Hydrocortisone Acetate (CORT) and Epinephrine Sulfate (EPI) in Depression, sponsored by Stanford University. Withdrawn. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Stanford University · Early Phase 1, Interventional, and Basic science

Why this study was withdrawn
Principal Investigator left lab before study start
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Healthy Arm, CORT + EPI, then PLB + EPI

    Healthy participant will receive cortisol pill and epinephrine infusion

    Drug: Hydrocortisone Acetate (CORT) · Drug: Epinephrine Sulfate (EPI)

  • Active comparator
    Healthy Arm, PLB + EPI, then CORT + EPI

    Healthy participant will receive placebo pill and epinephrine infusion

    Drug: Epinephrine Sulfate (EPI) · Drug: Placebo (PLB)

  • Experimental
    Depression Arm, CORT + EPI, then PLB + EPI

    Depressed participant will receive cortisol pill and epinephrine infusion

    Drug: Hydrocortisone Acetate (CORT) · Drug: Epinephrine Sulfate (EPI)

  • Experimental
    Depression Arm, PLB + EPI, then CORT + EPI

    Depressed participant will receive placebo pill and epinephrine infusion

    Drug: Epinephrine Sulfate (EPI) · Drug: Placebo (PLB)

Interventions

  • DrugHydrocortisone Acetate (CORT)

    Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg

    Also known as: Cortef

  • DrugEpinephrine Sulfate (EPI)

    Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min

    Also known as: Adrenalin

  • DrugPlacebo (PLB)

    Participants will receive a placebo

06

What researchers measure

Primary outcomes

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

    Time frame: 2 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04148261
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
Nov 1, 2019
Start date
Dec 2020 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Oct 6, 2021

Study contacts

Keith Sudheimer, Ph.D.
principal investigator · Stanford University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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