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The Evaluation of Women With Perimenopause-Related Mood and Behavioral Disorders
This study is currently Recruiting
June 2011 By National Institutes of Health Clinical Center (CC)
First Recieved on November 3, 1999
Last Updated on June 24, 2011
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
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....
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Ages Eligible for Study:||40 Years|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
- PATIENT/VOLUNTEER INCLUSION CRITERIA:
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;
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; and.
In good medical health
Subjects must be competent to comprehend the purpose of the screening process and to
provide written informed consent and be willing to participate in NIMH IRB approved
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 INCLUSION CRITERIA:
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 disturbance as determined by a structured diagnostic
Plasma gonadotropin levels in pre-perimenopausal range (less than 14 IU/L);
In good medical health; and
GENETIC STUDIES INCLUSION CRITERIA:
Unaffected family members of women with perimenopausal depression will be admitted for
genetic studies only.
First degree relatives of women with confirmed perimenopausal depression, who do not have
perimenopausal depression as defined in this protocol.