Clinical studies on the efficacy of agomelatine on depressive symptoms.

The novel mechanism of action of agomelatine, with affinity for melatonergic and 5-HT(2C) receptors, offers the prospect of efficacy in major depression and anxiety with minimal adverse effects. The challenge of performing acute placebo-controlled treatment trials in a relevant sample of patients with moderate to severe major depression is considerable. The efficacy of active treatment may be obscured by excessive responses in placebo and active treatment arms. The agomelatine programme has successfully introduced methodological innovation to overcome this risk and ensure that cases of major depression display adequate severity on both ratings of symptoms and measures of functional impairment. The efficacy of agomelatine in major depression has thus been demonstrated at doses of 25-50 mg against the full range of symptoms that make up the depressive syndrome in patients with moderate to severe major depression.