The Evaluation of Women With Perimenopause-Related Mood and Behavioral Disorders

• INCLUSION CRITERIA:

• Perimenopausal Subjects:

  • 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 40-65;
  • 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 (> 14IU/L) (as recommended by the Stages of Reproductive Aging Workshop criteria (106)) 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 research protocols.

• 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.

• Premenopausal women will be women who meet the following 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:

• Primary general medical illness (i.e., appears to be causing the mood disorder);
• Current antidepressant therapy (since this is a screening protocol for subsequent treatment studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them;
• Current alcohol or substance abuse 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);
• Pregnant or lactating women;
• Subjects who are unable to provide informed consent.
• NIMH employees, staff and their immediate family members will be excluded from the study per NIMH policy.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety