HealthyNCT00055003
Effect of Hydrocortisone on the Brain
An observational study of Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to use brain imaging technology to examine the effect of the hormone hydrocortisone on the brain's response to various facial expressions. Glucocorticoids can influence emotional behavior and cognition; when given long-term, the hormones may lead to mania or depression. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Healthy
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2003to 18 Nov 2010
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects will be between 18 and 50 years old.
- Male and female subjects will be included.
- Females will be studied in the luteal phase.
- All subjects must be able to give written informed consent prior to participation in this study.
Who cannot join
- Children less than 18.
- Individuals with any major medical or neurological disorder, or taking any medication within 3 weeks of scanning that is likely to influence CBF or metabolism, or having any endocrine condition expected to be associated with abnormal HPA axis function.
- Individuals who meet DSM-IV criteria for alcohol and/or substance abuse within 1 year prior to screening or lifetime history of substance dependence.
- Individuals with a current or past history of other axis I psychiatric disorders.
- Individuals with first-degree family members with current or past history of mood disorder.
- Women of childbearing potential who have a positive pregnancy test who are currently nursing.
Show all 13Show fewer
- Individuals who have experienced serious suicidal ideation or attempt within the past 6 months.
- Smokers are ineligible to participate.
- Women with irregular menstrual cycles or taking oral contraceptives.
- Those with a weight greater than 100 kgs.
- Those with previous allergic reactions or hypersensitivity to hydrocortisone.
- General exclusions for MRI imaging, such as having had a cardiac pacemaker or ferromagnetic object implanted through surgical intervention or accident, e.g. shrapnel.
- Those with a history of peptic ulcer disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Effects of Hydrocortisone Infusion on Processing of Facially Expressed Emotion During Functional Magnetic Resonance Imaging
The purpose of this study is to use brain imaging technology to examine the effect of the hormone hydrocortisone on the brain's response to various facial expressions.
Glucocorticoids can influence emotional behavior and cognition; when given long-term, the hormones may lead to mania or depression. One way glucocorticoids may influence emotional behavior is by affecting the activity of certain parts of the brain that participate in emotional processing. Brain imaging studies indicate that the amygdala, ventral medial prefrontal, and other prefrontal cortical areas of the brain are activated during tasks that require processing of emotional stimuli. These brain structures contain dense concentrations of glucocorticoid receptors. This study will use functional magnetic resonance imaging (fMRI) to study the brain activity of participants as they view faces that express different emotions. Participants will perform this task under a dose of either the glucocorticoid hydrocortisone or placebo (an inactive solution).
Read more
Participants in this study will be screened with a medical history, physical examination, blood tests, and an interview about their mood, degree of nervousness, and behavior. On Visit 1, participants will undergo screening and neuropsychological testing. For 3 days prior to Visit 2, participants will collect their saliva. During Visit 2, participants will undergo MRI scans of the brain after infusion with either a high or low dose of hydrocortisone or placebo. Participants will also undergo functional MRI (fMRI). Blood samples will be collected every 15 minutes during the scan. Following the MRI, participants will take attention and memory tests.
...
Read the detailed description
Glucocorticoids influence performance on declarative memory tasks and tasks of memory for emotional information. The cognitive effects of exogenous glucocorticoids depend on dose, the time period between administration and testing, and the time of testing within the diurnal pattern of cortisol secretion. Additionally, glucocorticoid administration can influence mood, and with chronic administration glucocorticoids may lead to development of mania or depression.
A potential mechanism by which glucocorticoids may influence emotional behavior is via their effects on the neurophysiological activity of the amygdala and prefrontal cortical structures known to participate in emotional processing. Human imaging studies indicate that amygdala, ventral medial prefrontal, and other prefrontal cortical areas are activated during tasks requiring processing of affective stimuli. These data converge with lesion analysis and electrophysiological studies performed in humans or experimental animals to indicate that these structures participate in brain circuits that process emotional information. These brain structures contain dense concentrations of glucocorticoid and mineralocorticoid receptor mRNA, glucocorticoid receptors and mineralocorticoid receptors. Increased glucocorticoids appear to potentiate activation of the amygdala and affect processing of emotionally laden stimuli based on both experimental animal studies and correlational human studies.
The present study investigates the influence of glucocorticoids on the hemodynamic response that occurs while processing emotionally-valenced visual stimuli known to activate the amygdala and anatomically-related areas of the prefrontal cortex (PFC) in healthy humans. Functional magnetic resonance images will be acquired during the performance of tasks that involve viewing emotionally expressive faces both before and following either hydrocortisone (synthetic cortisol) (0.15 mg/kg or 0.45 mg/kg bolus) or placebo administration. The change in the BOLD signal in structures of interest will be compared across high dose cortisol, low dose cortisol and placebo conditions. In addition, the effects of hydrocortisone on relative blood flow in the amygdala and PFC will be assessed using an arterial spin labeling (ASL) technique to measure perfusion. The findings of this study will guide future research into the effects of glucocorticoids on emotional perception in subjects with mood disorders.
- Conditions
- Healthy
- Keywords
- Amygdala, Medial Prefrontal Cortex, Orbitofrontal Cortex, Cortisol, Memory, Glucocorticoid, Hydrocortisone, Stress, Perception, Affect, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2003 (estimated)
- Study start13 Feb 2003
- Study completion18 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Observational
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055003
- Sponsor's protocol ID
- 030102
- Other IDs
- 03-M-0102
- Status last verified
- 18 Nov 2010
- First submitted
- 15 Feb 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Buchanan TW, Lovallo WR. Enhanced memory for emotional material following stress-level cortisol treatment in humans. Psychoneuroendocrinology. 2001 Apr;26(3):307-17. doi: 10.1016/s0306-4530(00)00058-5.
PubMed 11166493Nejtek VA. High and low emotion events influence emotional stress perceptions and are associated with salivary cortisol response changes in a consecutive stress paradigm. Psychoneuroendocrinology. 2002 Apr;27(3):337-52. doi: 10.1016/s0306-4530(01)00055-5.
PubMed 11818170Newcomer JW, Selke G, Melson AK, Hershey T, Craft S, Richards K, Alderson AL. Decreased memory performance in healthy humans induced by stress-level cortisol treatment. Arch Gen Psychiatry. 1999 Jun;56(6):527-33. doi: 10.1001/archpsyc.56.6.527.
PubMed 10359467
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrocortisone Infusion on Processing of Facially Expressed Emotion During Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00055003
- Acronym / sponsor ID
- 030102
- Conditions
- Healthy
- Keywords
- Amygdala, Medial Prefrontal Cortex, Orbitofrontal Cortex, Cortisol, Memory, Glucocorticoid, Hydrocortisone, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 13 Feb 2003
- Study completion
- 18 Nov 2010
- First posted
- 17 Feb 2003 (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.
The purpose of this study is to use brain imaging technology to examine the effect of the hormone hydrocortisone on the brain's response to various facial expressions.
Glucocorticoids can influence emotional behavior and cognition; when given long-term, the hormones may lead to mania or depression. One way glucocorticoids may influence emotional behavior is by affecting the activity of certain parts of the brain that participate in emotional processing. Brain imaging studies indicate that the amygdala, ventral medial prefrontal, and other prefrontal cortical areas of the brain are activated during tasks that require processing of emotional stimuli. These brain structures contain dense concentrations of glucocorticoid receptors. This study will use functional magnetic resonance imaging (fMRI) to study the brain activity of participants as they view faces that express different emotions. Participants will perform this task under a dose of either the glucocorticoid hydrocortisone or placebo (an inactive solution).
Participants in this study will be screened with a medical history, physical examination, blood tests, and an interview about their mood, degree of nervousness, and behavior. On Visit 1, participants will undergo screening and neuropsychological testing. For 3 days prior to Visit 2, participants will collect their saliva. During Visit 2, participants will undergo MRI scans of the brain after infusion with either a high or low dose of hydrocortisone or placebo. Participants will also undergo functional MRI (fMRI). Blood samples will be collected every 15 minutes during the scan. Following the MRI, participants will take attention and memory tests.
...
Detailed description
Glucocorticoids influence performance on declarative memory tasks and tasks of memory for emotional information. The cognitive effects of exogenous glucocorticoids depend on dose, the time period between administration and testing, and the time of testing within the diurnal pattern of cortisol secretion. Additionally, glucocorticoid administration can influence mood, and with chronic administration glucocorticoids may lead to development of mania or depression.
A potential mechanism by which glucocorticoids may influence emotional behavior is via their effects on the neurophysiological activity of the amygdala and prefrontal cortical structures known to participate in emotional processing. Human imaging studies indicate that amygdala, ventral medial prefrontal, and other prefrontal cortical areas are activated during tasks requiring processing of affective stimuli. These data converge with lesion analysis and electrophysiological studies performed in humans or experimental animals to indicate that these structures participate in brain circuits that process emotional information. These brain structures contain dense concentrations of glucocorticoid and mineralocorticoid receptor mRNA, glucocorticoid receptors and mineralocorticoid receptors. Increased glucocorticoids appear to potentiate activation of the amygdala and affect processing of emotionally laden stimuli based on both experimental animal studies and correlational human studies.
The present study investigates the influence of glucocorticoids on the hemodynamic response that occurs while processing emotionally-valenced visual stimuli known to activate the amygdala and anatomically-related areas of the prefrontal cortex (PFC) in healthy humans. Functional magnetic resonance images will be acquired during the performance of tasks that involve viewing emotionally expressive faces both before and following either hydrocortisone (synthetic cortisol) (0.15 mg/kg or 0.45 mg/kg bolus) or placebo administration. The change in the BOLD signal in structures of interest will be compared across high dose cortisol, low dose cortisol and placebo conditions. In addition, the effects of hydrocortisone on relative blood flow in the amygdala and PFC will be assessed using an arterial spin labeling (ASL) technique to measure perfusion. The findings of this study will guide future research into the effects of glucocorticoids on emotional perception in subjects with mood disorders.
Study design
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All subjects will be between 18 and 50 years old.
- Male and female subjects will be included.
- Females will be studied in the luteal phase.
- All subjects must be able to give written informed consent prior to participation in this study.
Key exclusion criteria (13 listed)
- Children less than 18.
- Individuals with any major medical or neurological disorder, or taking any medication within 3 weeks of scanning that is likely to influence CBF or metabolism, or having any endocrine condition expected to be associated with abnormal HPA axis function.
- Individuals who meet DSM-IV criteria for alcohol and/or substance abuse within 1 year prior to screening or lifetime history of substance dependence.
- Individuals with a current or past history of other axis I psychiatric disorders.
- Individuals with first-degree family members with current or past history of mood disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 11166493Buchanan TW, Lovallo WR. Enhanced memory for emotional material following stress-level cortisol treatment in humans. Psychoneuroendocrinology. 2001 Apr;26(3):307-17. doi: 10.1016/s0306-4530(00)00058-5.
- Background: PubMed 11818170Nejtek VA. High and low emotion events influence emotional stress perceptions and are associated with salivary cortisol response changes in a consecutive stress paradigm. Psychoneuroendocrinology. 2002 Apr;27(3):337-52. doi: 10.1016/s0306-4530(01)00055-5.
- Background: PubMed 10359467Newcomer JW, Selke G, Melson AK, Hershey T, Craft S, Richards K, Alderson AL. Decreased memory performance in healthy humans induced by stress-level cortisol treatment. Arch Gen Psychiatry. 1999 Jun;56(6):527-33. doi: 10.1001/archpsyc.56.6.527.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Mental Health (NIMH) 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 4 inclusion and 13 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 2 Jul 2017. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00055003, which also lists 3 linked publications.
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 2 Jul 2017.