Effect of Hydrocortisone on the Brain
Effects of Hydrocortisone Infusion on Processing of Facially Expressed Emotion During Functional Magnetic Resonance Imaging
2 other identifiers
observational
80
1 country
1
Brief 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. 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. ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2003
CompletedFirst Submitted
Initial submission to the registry
February 15, 2003
CompletedFirst Posted
Study publicly available on registry
February 17, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2010
CompletedJuly 2, 2017
November 18, 2010
February 15, 2003
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- Those with a history of peptic ulcer disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
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.
PMID: 11166493BACKGROUNDNejtek 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.
PMID: 11818170BACKGROUNDNewcomer 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.
PMID: 10359467BACKGROUND
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 15, 2003
First Posted
February 17, 2003
Study Start
February 13, 2003
Study Completion
November 18, 2010
Last Updated
July 2, 2017
Record last verified: 2010-11-18