DepressionEarly Phase 1NCT04148261
Epinephrine and Cortisol in Depression
A Early Phase 1 study testing Hydrocortisone Acetate (CORT) and Epinephrine Sulfate (EPI) in people with Depression, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Hydrocortisone Acetate (CORT) and Epinephrine Sulfate (EPI)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight of less than 280 pounds
- HAM-D Score of greater than 7 for depression participants
Who cannot join
- Psychotropic medications
- Recent surgery
- Endocrine disorders
- Liver disease
- Kidney disease
- Thyroid disorder
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- 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
About this study
Official title: The Effects of Epinephrine and Cortisol on Emotion in Depression
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.
- Conditions
- Depression
- Being tested
- Hydrocortisone Acetate (CORT), Epinephrine Sulfate (EPI), Placebo (PLB)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone Acetate (CORT)Drug
Also called Cortef
Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg
Epinephrine Sulfate (EPI)Drug
Also called Adrenalin
Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
Placebo (PLB)Drug
Participants will receive a placebo
| Study group | Role | What they receive |
|---|---|---|
| Healthy Arm, CORT + EPI, then PLB + EPI | Active comparator | Healthy participant will receive cortisol pill and epinephrine infusion Receives: Drug: Hydrocortisone Acetate (CORT); Drug: Epinephrine Sulfate (EPI) |
| Healthy Arm, PLB + EPI, then CORT + EPI | Active comparator | Healthy participant will receive placebo pill and epinephrine infusion Receives: Drug: Epinephrine Sulfate (EPI); Drug: Placebo (PLB) |
| Depression Arm, CORT + EPI, then PLB + EPI | Experimental | Depressed participant will receive cortisol pill and epinephrine infusion Receives: Drug: Hydrocortisone Acetate (CORT); Drug: Epinephrine Sulfate (EPI) |
| Depression Arm, PLB + EPI, then CORT + EPI | Experimental | Depressed participant will receive placebo pill and epinephrine infusion Receives: Drug: Epinephrine Sulfate (EPI); Drug: Placebo (PLB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Principal Investigator left lab before study start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Sudheimer, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148261
- Sponsor's protocol ID
- 53325
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Epinephrine and Cortisol on Emotion in Depression
- ClinicalTrials.gov ID
- NCT04148261
- Acronym / sponsor ID
- 53325
- Conditions
- Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left lab before study start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Arm, CORT + EPI, then PLB + EPI | Active comparator | Drug: Hydrocortisone Acetate (CORT), Drug: Epinephrine Sulfate (EPI)Healthy participant will receive cortisol pill and epinephrine infusion |
| Healthy Arm, PLB + EPI, then CORT + EPI | Active comparator | Drug: Epinephrine Sulfate (EPI), Drug: Placebo (PLB)Healthy participant will receive placebo pill and epinephrine infusion |
| Depression Arm, CORT + EPI, then PLB + EPI | Experimental | Drug: Hydrocortisone Acetate (CORT), Drug: Epinephrine Sulfate (EPI)Depressed participant will receive cortisol pill and epinephrine infusion |
| Depression Arm, PLB + EPI, then CORT + EPI | Experimental | Drug: Epinephrine Sulfate (EPI), Drug: Placebo (PLB)Depressed participant will receive placebo pill and epinephrine infusion |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weight of less than 280 pounds
- HAM-D Score of greater than 7 for depression participants
Key exclusion criteria (33 listed)
- Psychotropic medications
- Recent surgery
- Endocrine disorders
- Liver disease
- Kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone Acetate (CORT)Also: CortefParticipants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg | Drug | Depression Arm, CORT + EPI, then PLB + EPI, Healthy Arm, CORT + EPI, then PLB + EPI |
| Epinephrine Sulfate (EPI)Also: AdrenalinParticipants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min | Drug | Depression Arm, CORT + EPI, then PLB + EPI, Depression Arm, PLB + EPI, then CORT + EPI, Healthy Arm, CORT + EPI, then PLB + EPI, Healthy Arm, PLB + EPI, then CORT + EPI |
| Placebo (PLB)Participants will receive a placebo | Drug | Depression Arm, PLB + EPI, then CORT + EPI, Healthy Arm, PLB + EPI, then CORT + EPI |
Primary outcome
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging
Time frame: 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Sudheimer, Ph.D. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydrocortisone Acetate (CORT) and Epinephrine Sulfate (EPI) in people with Depression, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.