Study of the Hypothalmic-Pituitary-Adrenal (HPA) Axis and Its Role in Major Depression
Intensively Sampled Dynamics of ACTH and Cortisol Affective Disorders
2 other identifiers
observational
60
1 country
1
Brief Summary
Major depression represents a major public health problem worldwide and in the U.S. Fifteen percent of the U.S. population has depression at some point in life (40 million individuals). The condition is more common in women, occurring at a female to male ratio of 5:2. Presently, 6-8% of all outpatients in primary care meet the diagnostic criteria for major depression. Fifteen percent of untreated patients with depression will commit suicide. Most of the people committing suicide are depressed. Researchers believe that by the year 2020 suicide will be the 10th most common cause of death in the U.S. In addition to mortality due to suicide, depression is also associated with other severe health conditions. Areas of the brain (hippocampus) begin to deteriorate, heart disease, and decreased bone mineral density (osteoporosis) are all associated with major depression. Researchers have believed for years that hormones controlled by the hypothalmus, pituitary gland, and adrenal gland (commonly referred to as the HPA axis or system) are in some way associated with psychiatric illnesses like depression. According to previous studies, researchers have theorized that increased activity of the HPA axis is associated with depressed patients with typical melancholic features. Melancholia refers to the feelings of anhedonia (absence of pleasure from activites that would normally be thought of as pleasurable), insomnia (inability to sleep), guilt, and psychomotor changes. On the other hand a decrease in activity of the HPA axis may be associated with the atypical features of depression. This study has already developed and refined studies that have improved the understanding of the HPA axis in healthy humans and depressed patients. Researchers have already identified and plan to continue identifying distinct subtypes of depressive disorders based on the activity of the HPA axis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 1995
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
January 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2000
CompletedFirst Posted
Study publicly available on registry
December 10, 2002
CompletedMarch 4, 2008
June 1, 1999
November 3, 1999
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may not qualify if:
- Subjects on chronic medications, which can not be washed out in one month.
- Subjects with any serious medical illnesses which have been excluded.
- Women who are pregnant, trying to become pregnant or sexually active and not using effective contraception.
- Patients with HIV-1 infection.
- Patients on chronic lithium therapy.
- Subjects unable to discontinue alcohol, tobacco, or illegal drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Babloyantz A, Destexhe A. Low-dimensional chaos in an instance of epilepsy. Proc Natl Acad Sci U S A. 1986 May;83(10):3513-7. doi: 10.1073/pnas.83.10.3513.
PMID: 3085091BACKGROUNDDemitrack MA, Dale JK, Straus SE, Laue L, Listwak SJ, Kruesi MJ, Chrousos GP, Gold PW. Evidence for impaired activation of the hypothalamic-pituitary-adrenal axis in patients with chronic fatigue syndrome. J Clin Endocrinol Metab. 1991 Dec;73(6):1224-34. doi: 10.1210/jcem-73-6-1224.
PMID: 1659582BACKGROUNDGarfinkel A, Spano ML, Ditto WL, Weiss JN. Controlling cardiac chaos. Science. 1992 Aug 28;257(5074):1230-5. doi: 10.1126/science.1519060.
PMID: 1519060BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
December 10, 2002
Study Start
January 1, 1995
Study Completion
May 1, 2000
Last Updated
March 4, 2008
Record last verified: 1999-06