Perimenopause-Related Mood and Behavioral Disorders

Conditions Phase Intervention Type
    Perimenopausal Depression Healthy Problem Behavior Depressive Disorder Depression
N/A

Eligibility

Ages Eligible for Study
40 years to 60 years
Genders Eligible for Study
F

Keywords

Mood, Behavior, Cognition, Climacteric, Menopause, Perimenopause, Midlife, and Depression

Sponsors

NIH
National Institute of Mental Health (NIMH)

Inclusion Criteria

for the
longitudinal study participants:

- Regular menstrual cycle function (21-34 days);

- Absence of current mood or behavioral disturbance as determined by a structured
diagnostic interview;

- Plasma gonadotropin levels in pre-perimenopausal range (<14 IU/L);

- In good medical health; and

- Medication free.

Exclusion Criteria

for the Dex/CRH protocol:

- Pregnant or plan to become pregnant within the next 6 months,

- Sexually active and are not willing to use a barrier method of birth control such as
a diaphragm or condom with spermicide,

- Heart or lung disease, chest pain, frequent shortness of breath, trouble breathing
while lying down flat or at serious for heart disease (for example, if you have high
blood pressure or a very high cholesterol level),

- Current medical illness, fever, or a chronic medical condition,

- Taking medication regularly, or not able to stop taking over-the-counter medications
other than acetaminophen (Tylenol), completely for one week before having the study
testing.

Detailed Description

The purpose of this study is to investigate mood and behavior changes in the time period surrounding and including menopause. This is an observational study; volunteers who participate will not receive any new or experimental therapies. Controversy exists regarding the relationship between estrogen and progesterone (gonadal steroid) changes and midlife-onset depression. This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders. Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression. Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators (SERMS). A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001231

Overall Contact Backup

Peter J Schmidt, M.D.
(301) 496-6120

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland United States

    Status: Recruiting

    Contact info For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
    800-411-1222xTTY8664111010