Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women

NCT00005768 | Unknown Phase 2

• 2 other identifiers: NCRR-M01RR00109-0741M01RR000109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. Women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (\>70 yrs. of age) will take estrogen or placebo for three months. At the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). Previous research has shown that these dietary manipulations can briefly produce negative changes in mood. The investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. The investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. The proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.

Conditions

Menopause

Interventions

Estrogen DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal
• Non-smoker
• BMI \<30
• Healthy
• Without surgically-induced menopause
• Not on HRT or \>1 year post HRT
• Normal mammogram within last year
• No cardiovascular disease other than mild hypertension

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Interventions

Estrogens

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Julie Dumas

CONTACT

1-802-847-2523

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 1, 2000
• First Posted: June 2, 2000
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)