Effects of Sex Hormones on Circadian Rhythm in Men and Women

NCT00001285 | Completed

• 2 other identifiers: 91020691-M-0206
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

For many years researchers have been trying to better understand the regulation of sleep and activity by studying circadian (daily) rhythms of human beings. It appears that the hormones estrogen, progesterone, and testosterone play a role in the regulation of circadian rhythm in animals. Researchers believe these hormones may also play a similar role in the regulation of human circadian rhythms. Little research has been conducted on how these hormones affect human circadian rhythms. This study is designed to learn more about how specific hormones influence men and women's daily rhythms. This study will use women from another research study being conducted at the NIMH called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone". Male subjects will be recruited from another NIMH study called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement". In order to test the possibility that gonadal steroids (estrogen, progesterone, and testosterone) change circadian rhythms and the sleep-wake cycle in humans, participants will undergo chronobiologic evaluations. The chronobiologic evaluations will look at sleep and rest periods, activity as measured by a wrist monitor, and 24 hour inpatient electroencephalograph (EEG), rectal temperature, and melatonin monitoring.

Conditions

Bipolar Disorder; Circadian Rhythm; Depressive Disorder

Keywords

Circadian Rhythms; Environmental Light; Estrogen; Melatonin; Progesterone; Rapid Cycling Bipolar Disorder; Sleep; Testosterone; Depression; Hypomania; Mania

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Volunteers must be healthy individuals between the ages of 18 and 45 years old. No pregnant women. No history of menstrually-related mood or behavioral disturbances. No volunteers with current or past Axis I diagnoses, significant abnormalities on physical or neurological examination, or significant laboratory abnormalities. Must be HIV negative.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Leibenluft E. Do gonadal steroids regulate circadian rhythms in humans? J Affect Disord. 1993 Oct-Nov;29(2-3):175-81. doi: 10.1016/0165-0327(93)90031-e.

  PMID: 8300976 BACKGROUND

• Leibenluft E, Schmidt PJ, Turner EH, Danaceau MA, Ashman SB, Wehr TA, Rubinow DR. Effects of leuprolide-induced hypogonadism and testosterone replacement on sleep, melatonin, and prolactin secretion in men. J Clin Endocrinol Metab. 1997 Oct;82(10):3203-7. doi: 10.1210/jcem.82.10.4270.

  PMID: 9329339 BACKGROUND

• Albers HE. Gonadal hormones organize and modulate the circadian system of the rat. Am J Physiol. 1981 Jul;241(1):R62-6. doi: 10.1152/ajpregu.1981.241.1.R62.

  PMID: 7246802 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder; Depression; Mania

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: August 1, 1991
• Study Completion: June 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-10

Locations

US (1)