Phase
Condition
Depression
Affective Disorders
Mood Disorders
Treatment
N/AClinical Study ID
Ages 40-65 Female
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA:
Perimenopausal Subjects:
History within the last one year of at least one month withperimenopause-related mood or behavioral disturbances of at least moderateseverity - that is, disturbances that are distinct in appearance and associatedwith a notable degree of functional impairment;
Age 40-65;
History of the onset of menstrual irregularity during the past six months butnot 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 (> 14IU/L) (asrecommended by the Stages of Reproductive Aging Workshop criteria (106)) drawnat two week intervals over a period of eight weeks;
No prior estrogen replacement therapy for treatment of perimenopausal physicalor emotional symptoms within the last six months; and
In good medical health;
Subjects must be competent to comprehend the purpose of the screening processand to provide written informed consent and be willing to participate in NIMHIRB approved research protocols.
A control group of age-matched perimenopausal women who meet patient selectioncriteria with the exception of the presence of mood or behavioral disorders willalso be sought.
Premenopausal women will be women who meet the following inclusion criteria for thelongitudinal study participants:
Regular menstrual cycle function (21-34 days);
Absence of current mood or behavioral disturbance as determined by a structureddiagnostic interview;
Plasma gonadotropin levels in pre-perimenopausal range (<14 IU/L);
In good medical health; and
Medication free.
Exclusion
EXCLUSION CRITERIA:
Primary general medical illness (i.e., appears to be causing the mood disorder);
Current antidepressant therapy (since this is a screening protocol for subsequenttreatment studies in which participants must be untreated). Antidepressants will notbe withheld from participants who need or want them;
Current alcohol or substance abuse or dependence (excluding nicotine) of sufficientmagnitude to require independent, concurrent treatment intervention (e.g., antabuseor opiate treatment, but not including self-help groups);
Pregnant or lactating women;
Subjects who are unable to provide informed consent.
NIMH employees, staff and their immediate family members will be excluded from thestudy per NIMH policy.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesSite Not Available

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