Pharmacopsychiatry. 2006 Nov;39(6):213-9.
Comparison of Hypericum Extract WS(R) 5570 and Paroxetine in Ongoing Treatment after Recovery from an Episode of Moderate to Severe Depression: Results from a Randomized Multicenter Study.
Anghelescu IG, Kohnen R, Szegedi A, Klement S, Kieser M. Department of Psychiatry and Psychotherapy, Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
OBJECTIVE: To test and compare the efficacy and safety of Hypericum extract WS ((R)) 5570 to paroxetine, a potent SSRI, in patients suffering from moderate or severe depression according to DSM-IV criteria. METHODS: In a multicenter, randomized, double-blind phase III study, the changes in moderate to severe major depression DSM-IV; 17-item Hamilton Depression Rating Scale (HAM-D total >/=22) after an acute treatment with Hypericum extract WS ((R)) 5570 or paroxetine were analyzed in a 16-week continuation phase for relapse prevention. Patients with a HAM-D total score decrease of >/=50% during the 6 weeks of acute treatment were asked to continue the treatment for another 4 months. One-hundred and thirty-three adult out-patients who received maintenance doses of 900 (n=33) or 1800 mg/d (n=38) of WS ((R)) 5570 and 20 (n=28) or 40 mg/d (n=34) of paroxetine, respectively, were included. The relevant dosage was already fixed during the acute treatment. RESULTS: Between baseline of the acute phase and end of continuation treatment the HAM-D total score decreased from 25.3+/-2.5 (mean+/-SD) to 4.3+/-6.2 points for WS ((R)) 5570 and from 25.3+/-2.6 to 5.2+/-5.5 points for paroxetine (p=0.49, two-sided t-test; median relative decrease: 92.0 and 85.5%, respectively). During maintenance treatment alone (day 154 - day 42), 61.6% of the patients randomized to WS ((R)) 5570 and 54.6% treated with paroxetine showed an additional reduction (p=0.59) with respect to the HAM-D total score. Remission (HAM-D endpoint total score below 8) occurred in 81.6% (31 patients) of the patients for WS ((R)) 5570 and in 71.4% (30 patients) for paroxetine (p=0.29). Three patients in the WS ((R)) 5570 group and 2 patients in the paroxetine group showed a HAM-D increase >5 points during continuation treatment. In the continuation phase there were 0.006 adverse events per day of exposure for WS ((R)) 5570 and 0.007 events for paroxetine. CONCLUSION: This study showed that WS ((R)) 5570 and paroxetine were similarly effective in preventing relapse in a continuation treatment after recovery from an episode of moderate to severe depression and point therefore to an important alternative treatment option for long-term relapse-prevention.
PMID: 17124643 [PubMed - in process]
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