Perimenopause-Related Mood and Behavioral Disorders
Condition: Mood Disorder
MeSH terms: Mood Disorders
Study type: Observational

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.
    

Detailed description: 
      Controversy exists regarding the relevance of changes in gonadal steroids for midlife onset
      depressions. The purpose of this protocol is to allow for the careful screening of patients
      and healthy volunteers for participation in research protocols that examine the role of
      gonadal steroids in depressions occurring during the perimenopause and for the collection of
      natural history data. Women in this protocol will undergo an evaluation which may include: a
      psychiatric diagnostic interview; rating scales; a medical history; a physical exam; blood
      and urine laboratory evaluation; and a request for medical records. The data collected may
      also be linked with data from other perimenopausal depression protocols (e.g., DNA,
      psychophysiology tests, treatment studies, etc.) for the purposes of better understanding the
      diagnosis, pathophysiology, and treatment response of women with depression during the
      perimenopause.Upon conclusion of the screening process, participants will either be offered
      entry into a research protocol and will sign the appropriate informed consent, or will be
      considered not appropriate for participation in research and will be referred back into the
      community. The second purpose of this protocol is to permit the identification of
      premenopausal women who are followed longitudinally through the menopause transition in an
      effort to confirm the association of depression onset with change in reproductive endocrine
      function. This protocol, then, serves as a screening and evaluation protocol to recruit
      subjects who are characterized with standard measures in this protocol and then offered
      participation in related studies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both depressed and asymptomatic women who are in the perimenopause.
      
Keywords: Mood; Behavior; Cognition; Midlife; Depression