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Trial record 40 of 1357 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"

Epinephrine and Cortisol in Depression

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ClinicalTrials.gov Identifier: NCT04148261
Recruitment Status : Not yet recruiting
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Keith Sudheimer, 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.

Condition or disease Intervention/treatment Phase
Depression Drug: Hydrocortisone Acetate (CORT) Drug: Epinephrine Sulfate (EPI) Drug: Placebo (PLB) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


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 Name: Cortef

Drug: Epinephrine Sulfate (EPI)
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Other Name: 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 Name: 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 Name: Cortef

Drug: Epinephrine Sulfate (EPI)
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Other Name: 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 Name: Adrenalin

Drug: Placebo (PLB)
Participants will receive a placebo




Primary Outcome Measures :
  1. Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging [ Time Frame: 2 hours ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148261


Contacts
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Contact: Keith Sudheimer, Ph.D. (650) 701-3674 ksudheim@stanford.edu
Contact: Dalton Duvio, B.A. (650) 427-9091 dlduvio@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Keith Sudheimer, Ph.D. Stanford University

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Responsible Party: Keith Sudheimer, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04148261     History of Changes
Other Study ID Numbers: 53325
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents