The International Journal of Neuropsychopharmacology



Hypericum extract in patients with MDD and reversed vegetative signs: re-analysis from data of a double-blind, randomized trial of hypericum extract, fluoxetine, and placebo


Harald Murck a1c1, Maurizio Fava a2, Jonathan Alpert a2, Andrew A. Nierenberg a2, David Mischoulon a2, Michael W. Otto a2, John Zajecka a3, Marcus Mannel a4 and Jerrold F. Rosenbaum a2
a1 Lichtwer Pharma GmbH, Berlin, Germany
a2 Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA
a3 Department of Psychiatry, Rush–Presbyterian–St Luke's Medical Center, Chicago, IL, USA
a4 Ad libitum Medical Services, Berlin, Germany

Article author query
murck h   [PubMed][Google Scholar] 
fava m   [PubMed][Google Scholar] 
alpert j   [PubMed][Google Scholar] 
nierenberg aa   [PubMed][Google Scholar] 
mischoulon d   [PubMed][Google Scholar] 
otto mw   [PubMed][Google Scholar] 
zajecka j   [PubMed][Google Scholar] 
mannel m   [PubMed][Google Scholar] 
rosenbaum jf   [PubMed][Google Scholar] 

Abstract

Hypericum extract (HE) might be favourably active in depressed patients with reversed vegetative signs (RVS). Therefore, we performed an exploratory subgroup analysis of a three-armed study to compare HE, fluoxetine, and placebo in patients with major depressive disorder (MDD) in a 12 wk trial. A total of 135 patients were randomized to 12 wk treatment with HE LI 160 (900 mg/d), fluoxetine (20 mg/d), or placebo. Patients with RVS were defined in two steps, according to DSM-IV. First, patients with melancholy-related vegetative signs were excluded. Secondly, patients had to have at least one score of 2 for the items 22–26 of the HAMD-28 scale, which are related to hypersomnia and hyperphagia. Twenty-seven patients remained in the group. Analysis of covariance (ANCOVA) was applied using the HAMD-17 score. Secondly a χ2 test for response was performed, using the same and further an adapted criterium as in recently published studies. ANCOVA revealed a trend to a global difference. Post-hoc analysis showed a trend to superiority of HE compared to placebo and to fluoxetine, but a very large effect size for both differences. Fluoxetine was not different from placebo. The adapted response criterium showed a significant global difference as well as a significant superiority of HE over placebo and over fluoxetine. These data are based on a small sample size and must be considered tentative. A characterization of vegetative features of patients with depression could lead to an overall increased effect size in the treatment with HE.

(Received February 10 2004)
(Reviewed April 28 2004)
(Revised June 3 2004)
(Accepted June 13 2004)


Key Words: Atypical depression; major depression; reversed vegetative signs; St. John's wort.

Correspondence:
c1 Laxdale Ltd, Laurelhill Business Park, Stirling, Scotland, UK. Tel.: ++44 1786 476044 Fax: ++44 1786 473137 E-mail: haraldmurck@yahoo.de