NCT00001479

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 1995

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

January 1, 1995

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

June 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

ACTHAdrenocorticotropic HormoneAntidepressant TreatmentChaos TheoryChronic Fatigue SyndromeMajor DepressionNormal VolunteerPrimary Affective Disorder

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 3085091BACKGROUND
  • Demitrack 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: 1659582BACKGROUND
  • Garfinkel 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

Fatigue Syndrome, ChronicMood DisordersDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersDepressive Disorder

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

Locations