NCT00055003

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2003

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2003

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2010

Completed
Last Updated

July 2, 2017

Status Verified

November 18, 2010

First QC Date

February 15, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

AmygdalaMedial Prefrontal CortexOrbitofrontal CortexCortisolMemoryGlucocorticoidHydrocortisoneStressPerceptionAffectHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 11166493BACKGROUND
  • Nejtek 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: 11818170BACKGROUND
  • Newcomer 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

Locations