DepressionEarly Phase 1NCT02837432
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
A Early Phase 1 study testing Hydrocortisone acetate in people with Depression, run by Stanford University at 1 site in United States.
Trial summary
There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Hydrocortisone acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 15 Nov 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Participants must have no Axis 1 mental disorder
- Participants with depression must meet minimum severity levels (Hamilton >7)
- All participants must weight less than 280 pounds for the purposes of MRI scanning
Who cannot join
- In order to protect against risk associated with taking Hydrocortisone, all participants must not have any of the following:
- Psychotropic medications
- Recent surgery
- Endocrine disorders
- Liver disease
- Kidney disease
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- Thyroid disorder
- History of malaria
- Tuberculosis
- Osteoporosis
- Glaucoma/cataracts
- Chronic expressed infections (herpes --including ocular herpes, HIV, etc.)
- History of congestive heart failure
- History of recurring seizures
- Stomach Ulcers
- Comorbid psychosis
- Current use of illicit drugs
- High Blood pressure
- In order to protect against risks associated with MRI scanning participants must not be/have any of the following:
- >280 lbs
- In-dwelling ferrous metals
- Left Handed
- Abnormal Hearing
- Claustrophobic
- Head injury with loss of consciousness
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry and Behavioral Sciences, 401 Quarry Road
Stanford, California, 94305
About this study
There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This project investigates if the subgenual cingulate cortex has become insensitive to cortisol in patients with depression and tests for variants of the cortisol receptor genes that could predispose individuals to develop cortisol insensitivity.
- Conditions
- Depression
- Being tested
- Hydrocortisone acetate, Placebo
- Keywords
- Depression, Cortisol, Sadness, Genetics, Stress
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone acetateDrug
Also called Cortef
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Other | Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order Receives: Drug: Hydrocortisone acetate; Drug: Placebo |
| Depression | Other | Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order Receives: Drug: Hydrocortisone acetate; Drug: Placebo |
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 posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion13 Dec 2019
- Study completion15 Nov 2020
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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Sudheimer, Stanford University
- Investigators
- Keith Sudheimer, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837432
- Sponsor's protocol ID
- 19771
- Status last verified
- Oct 2021
- First submitted
- 15 Jul 2016
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
- ClinicalTrials.gov ID
- NCT02837432
- Acronym / sponsor ID
- 19771
- Conditions
- Depression
- Keywords
- Depression, Cortisol, Sadness, Genetics, Stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This project investigates if the subgenual cingulate cortex has become insensitive to cortisol in patients with depression and tests for variants of the cortisol receptor genes that could predispose individuals to develop cortisol insensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Other | Drug: Hydrocortisone acetate, Drug: PlaceboHealthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order |
| Depression | Other | Drug: Hydrocortisone acetate, Drug: PlaceboIndividuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Participants must have no Axis 1 mental disorder
- Participants with depression must meet minimum severity levels (Hamilton >7)
- All participants must weight less than 280 pounds for the purposes of MRI scanning
Key exclusion criteria (25 listed)
- In order to protect against risk associated with taking Hydrocortisone, all participants must not have any of the following:
- Psychotropic medications
- Recent surgery
- Endocrine disorders
- Liver 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 acetateAlso: Cortef | Drug | Depression, Healthy |
| Placebo | Drug | Depression, Healthy |
Primary outcome
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydrocortisone acetate in people with Depression, run by Stanford University at 1 site in United States.
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 3 inclusion and 25 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: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 22 Oct 2021.