Protocol Number: 88-M-0131

Title:

The Evaluation of 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: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

PATIENT/VOLUNTEER ENROLLMENT

CROSS-SECTIONAL SCREENING: The perimenopausal subjects of this protocol will be women who meet the following inclusion criteria:

History within the last one year of at least one month with perimenopause-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.

In good medical health

CONTROL GROUP INCLUSION CRITERIA:

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.

CONTROL GROUP EXCLUSION CRITERIA:

Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);

Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups)

LONGITUDINAL SCREENING: Pre-perimenopausal women will be women who meet the following inclusion criteria:

Regular menstrual cycle function (21-34 days),

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

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 Keyword(s):

None

Condition(s):

Depression

Healthy

Perimenopausal Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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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