Is severe depression a separate indication? ECNP Consensus Meeting September 20, 1996, Amsterdam. European College of Neuropsychopharmacology.

: There is not an accepted definition of severe depression, but using cut-off scores on rating scales severe depression is considered to lie at one extreme of a continuum of severity. The evidence from epidemiological, biological, and clinical efficacy studies does not support severe depression as a separate illness category. A good response to antidepressants is seen in both moderate and severe depression. The available evidence supports the view that in most cases an effective antidepressant in moderate depression is likely to have efficacy in severe depression. Few studies have found differences between antidepressants in their efficacy in treating severe depression. Most evidence of differential efficacy derives from studies of clomipramine, which is perceived as a particularly potent antidepressant by many clinicians. Other tricyclic antidepressants do not appear to have an advantage in severe depression. Separate studies to demonstrate efficacy in severe depression are not necessary for the registration of a new antidepressant. However if efficacy in severe depression is demonstrated in separate studies this information could be included in the summary of product characteristics to provide guidance to clinicians.