Epinephrine and Cortisol in Depression

Early Phase 1

Withdrawn

• Conditions: Depression
• Interventions: Drug: Hydrocortisone Acetate (CORT); Drug: Epinephrine Sulfate (EPI); Drug: Placebo (PLB)

• Registration Number: NCT04148261
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Study Start: 2020-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Arm, CORT + EPI, then PLB + EPI	Hydrocortisone Acetate (CORT)	Healthy participant will receive cortisol pill and epinephrine infusion
Healthy Arm, CORT + EPI, then PLB + EPI	Epinephrine Sulfate (EPI)	Healthy participant will receive cortisol pill and epinephrine infusion
Healthy Arm, PLB + EPI, then CORT + EPI	Epinephrine Sulfate (EPI)	Healthy participant will receive placebo pill and epinephrine infusion
Healthy Arm, PLB + EPI, then CORT + EPI	Placebo (PLB)	Healthy participant will receive placebo pill and epinephrine infusion
Depression Arm, CORT + EPI, then PLB + EPI	Hydrocortisone Acetate (CORT)	Depressed participant will receive cortisol pill and epinephrine infusion
Depression Arm, CORT + EPI, then PLB + EPI	Epinephrine Sulfate (EPI)	Depressed participant will receive cortisol pill and epinephrine infusion
Depression Arm, PLB + EPI, then CORT + EPI	Epinephrine Sulfate (EPI)	Depressed participant will receive placebo pill and epinephrine infusion
Depression Arm, PLB + EPI, then CORT + EPI	Placebo (PLB)	Depressed participant will receive placebo pill and epinephrine infusion

Primary Outcome Measures

Name	Time	Method
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging	2 hours