Epinephrine and Cortisol in Depression

NCT ID: NCT04148261

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Healthy Arm, CORT + EPI, then PLB + EPI

Healthy participant will receive cortisol pill and epinephrine infusion

Group Type ACTIVE_COMPARATOR

Hydrocortisone Acetate (CORT)

Intervention Type DRUG

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

Epinephrine Sulfate (EPI)

Intervention Type DRUG

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

Healthy Arm, PLB + EPI, then CORT + EPI

Healthy participant will receive placebo pill and epinephrine infusion

Group Type ACTIVE_COMPARATOR

Epinephrine Sulfate (EPI)

Intervention Type DRUG

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

Placebo (PLB)

Intervention Type DRUG

Participants will receive a placebo

Depression Arm, CORT + EPI, then PLB + EPI

Depressed participant will receive cortisol pill and epinephrine infusion

Group Type EXPERIMENTAL

Hydrocortisone Acetate (CORT)

Intervention Type DRUG

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

Epinephrine Sulfate (EPI)

Intervention Type DRUG

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

Depression Arm, PLB + EPI, then CORT + EPI

Depressed participant will receive placebo pill and epinephrine infusion

Group Type EXPERIMENTAL

Epinephrine Sulfate (EPI)

Intervention Type DRUG

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

Placebo (PLB)

Intervention Type DRUG

Participants will receive a placebo

Interventions

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Hydrocortisone Acetate (CORT)

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

Intervention Type DRUG

Epinephrine Sulfate (EPI)

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

Intervention Type DRUG

Placebo (PLB)

Participants will receive a placebo

Intervention Type DRUG

Other Intervention Names

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Cortef Adrenalin

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Sudheimer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

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53325

Identifier Type: -

Identifier Source: org_study_id

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