Ethyl-Eicosapentaenoate for depression with melancholic features

Aims: Preliminary data suggest that Ethyl-eicosapentaenoate (E-E) has efficacy in major depression (MDE). We now report the outcome of two randomized placebo controlled trials.

Methods: In Trial 1 E-E was used as adjunct therapy for patient with a MDE unresponsive to their standard therapy. 115 patients who had failed to respond to at least one antidepressant were randomised to receive 1g/d E-E or placebo for 12 weeks. In trial 2, E-E was used as monotherapy in 77 patients with a new episode of depression in a 6 week trial. Apart from the primary placebo-active comparison, the predictive value of the expressed presence of vegetative melancholic signs (VM: early morning awakening, appetite or weight loss, as defined by a score of 2 on items 6, 12 and 16 of the Hamilton Depression Rating Scale (HDRS) baseline and three different doses of E-E were explored. We used the HDRS and the DEP- subscale of the core depression items (item 1–3) of the HDRS.

Results: Consistently, in both trials E-E was superior to placebo in patients with VM; A repeated measurement design revealed a significant superiority of E-E on HDRS in trial 1 and of the DEP-Subscale in trial 2 (both (p<0.05). The effect size in the overall population was less pronounced.

Conclusion: Clinical differentiation of patients with depression may define biological subgroups with differential pharmacological response. E-E consistently shows benefits in patients with melancholic vegetative signs.