Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001479
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study of the Hypothalmic-Pituitary-Adrenal HPA Axis and Its Role in Major Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Intensively Sampled Dynamics of ACTH and Cortisol Affective Disorders
Status:
COMPLETED
Status Verified Date:
1999-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Major depression represents a major public health problem worldwide and in the US Fifteen percent of the US 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 52 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 US
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
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
Detailed Description:
Major depression represents a major public health problem worldwide and in the US Fifteen percent of the US population has depression at some point in life 40 million individuals with a female to male ratio 52 Presently 6-8 of all outpatients in primary care meet diagnostic criteria for major depression Fifteen percent of untreated depressed patients commit suicide-most suicides have depression In the US in the year 2020 suicide will be the 10th cause of death In addition to mortality due to suicide major depression is associated with severe morbidity that includes decreased hippocampal volume cardiovascular illness and decreased bone mineral density Moreover after myocardial infarction patients with depression have a higher mortality rate than those without depression adjusted risk ratio 429 Because such morbidity can be differentially affected either by increased or decreased levels of hypothalamic-pituitary-adrenal HPA function it is necessary to study HPA function in our populations Additionally based on our previous data we have hypothesized that depressed patients with melancholic features would have increase HPA function while those with atypical features would have decreased HPA function Using this protocol over the past four years we have developed refined and repeatedly conducted detailed patient-oriented studies that have expanded the frontiers of existing knowledge on HPA regulation in healthy humans and depressed subjects This protocol has already demonstrated the existence of two distinct biological subtypes of major depression with the important finding of a decrement of HPA function in patients with atypical features Thus the atypical classification is not restricted to phenotype but represents a subtype with specific biological characteristics This finding shows that there are unique strategies targets and potential interventional approaches to patients with either atypical or melancholic features The elucidation of the neuroendocrinology of major depression has been a key goal of our branch and this protocol offers the potential to unravel the biology of phenotypically distinct subtypes of major depression Moreover the elucidation of the medical consequences of major depression requires the precise longitudinal characterization of HPA function that is accomplished by this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-M-0044 | None | None | None |