Protocol Number: 88-M-0131

Title:

A Screening Protocol to Evaluate Women with Perimenopause-Related Mood and Behavioral Disorders

Number:

88-M-0131

Summary:

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria:

PATIENT/VOLUNTEER ENROLLMENT

CROSS-SECTIONAL SCREENING:

INCLUSION CRITERIA

Female.

History within the last one year of at least one month with perimenopause or midlife-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of functional impairment;

Age 40-60;

History of the onset of menstrual irregularity during the past six months but not greater than one year of amenorrhea (i.e., not postmenopausal);

Biological evidence of a deterioration of normal ovarian activity, specifically, plasma FSH levels persistently elevated (greater than 14 IU/L) drawn at two week intervals over a period of eight weeks;

No prior estrogen replacement therapy for treatment of perimenopausal physical or emotional symptoms within the last six months.

Good medical health

CONTROL GROUP

A control group of age-matched perimenopausal women who meet patient selection criteria with the exception of the presence of mood or behavioral disorders will also be sought.

LONGITUDINAL SCREENING:

The pre-perimenopausal women (regular cycling) will be women who meet the following criteria:

Female.

Regular menstrual cycle function (21-34 days),

Absence of current mood or behavioral disturbances as determined by a structured diagnostic interview,

Early follicular phase plasma gonadotropin levels in pre-perimenopausal range (less than 14 IU/L),

In good medical health,

Medication free.

Special Instructions:

Call referral contact for additional eligibility criteria.

Keywords:

Mood

Behavior

Cognition

Climacteric

Menopause

Perimenopause

Midlife

Depression

Recruitment Keywords:

None

Conditions:

Depressive Disorder

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Linda Simpson-St. Clair, R.N.
National Institutes of Health
Building 10
Room 3N238
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-9576
Fax: (301) 402-2588

Electronic Address: simpsonl@irp.nimh.nih.gov

Citations:

Sex and depression in the National Comorbidity Survey I: lifetime prevalence, chronicity and recurrence

Menopause-related affective disorders: a justification for further study

Estrogen replacement in perimenopause-related depression: a preliminary report

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