Hypericum extract WS® 5570 and paroxetine are comparably effective in continuation treatment after recovery from a moderate or severe depressive episode

Objective The efficacy of WS^® 5570 and paroxetine in continuation treatment after recovery from an acute episode.

Patients and methods We report on a follow-up to a double-blind, randomized treatment trial in out-patients with acute major depression according to DSM-IV, 17-item HAMD total score ≥22. Participants with a HAMD total score decrease ≥50% during 6 weeks of acute treatment were eligible for 4 months of double-blind continuation treatment with 900 or 1800mg/day Hypericum extract WS^® 5570 or with 20 or 40mg paroxetine. The primary outcome measure was the HAMD total score decrease between baseline and treatment end. Secondary measures included the MADRS, the CGI and the BDI.

Results 71 of 125 and 62 of 126 patients (WS^® 5570, paroxetine) entered continuation treatment. Across the entire study both groups showed comparable HAMD total score decreases by 20.9 (6.5) and 20.0 (5.6) points (WS^® 5570, paroxetine; p=0.49). 89.5% of the patients treated with WS^® 5570 and 92.9% of those in the paroxetine group showed sustained response (≥50% HAMD total score decrease; p=0.59). These results were supported by all secondary measures. During continuation treatment 0.006 and 0.007 adverse events per day of exposure were observed for WS^® 5570 and paroxetine, respectively.

Conclusions After recovery from a moderate or severe depressive episode WS^® 5570 and paroxetine were comparably effective and well tolerated during continuation treatment aimed at preventing of relapse.