In 1987, the selective serotonin (5HT) reuptake inhibitors (SSRIs; e.g., fluoxetine 1) were introduced into clinical use. Their improved safety and side effect profile resulted in a move away from older antidepressant agents, the tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Drugs for depression sold for an estimated $20 billion in the US in 2004, with growth predictions of 1.2% year-on-year. However, this is a mature market with a number of key drugs facing patent expiration in the next 6 years, and one that is awaiting the next paradigm shift in new chemical entity (NCE) treatment therapy.

Unipolar major depression is ranked fourth as a disease burden measured in disability adjusted for life years in 1990.8 Despite available antidepressant medications, unipolar major depression is ranked second behind ischemic heart disease as a potential disease burden by 2020. The risk for unipolar major depression, especially for females in developed countries, is 1 in 10. There is considerable evidence that depression is associated with increased risk for cardiovascular and infectious diseases as well as immunological and endocrine changes. The World Health Organization has predicted that depression will become the leading cause of human disability by 2020.1

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