BOX 3-1

Key Points: Depression

  • Major depressive disorder is a leading cause of disability worldwide. Depression is a significant contributor to other systemic and organ diseases.

  • While there has been some progress in treatment options, current approaches are inadequate.

  • Primary pathological mechanisms of depression are poorly characterized.

  • Women are 1.5 to 2.5 times more likely to experience major depression than men, from puberty onward. Symptomatology is also different between the sexes.

  • Sex differences must be studied across the lifespan:

    • Natural variation of hormone levels across the lifespan provides opportunities for the study of sex differences in psychiatric and neurological disorders.

    • Adult-onset disorders have developmental precursors.

    • Consideration of comorbid conditions is important.

  • Current animal models of depressive disorders have significant limitations at the levels of both concept and interpretation.

  • Sex and gender should be taken into account in every phase of drug development (Phases I through III and postmarketing studies, as well as preclinical studies in animals).


Sex Differences in Pain and Pain Perception

Studies in humans have shown that females generally experience more clinical pain and often show greater experimental pain responses (i.e., have lower thresholds and less tolerance for pain) than males, said Karen J. Berkley, professor of psychology and neuroscience at Florida State University. That difference, however, can be manipulated by a variety of experimental factors (e.g., stimulus type, pain scale used, testing paradigms, endpoints selected) and impacted by individual factors (e.g., age, reproductive status, general health, blood pressure, food intake, odors, social and cultural factors).

Although individuals show significant variability when it comes to alleviating pain, some generally accepted sex differences in pain are worth considering. First, more painful conditions have a higher prevalence in females than males. In other words, women are more likely to have painful chronic conditions than men. The underlying basis for this disparity is not known, but probably has multiple causes, Berkley said, and is an opportunity for further research. Second, hundreds of therapies are available to

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