PMID- 20181361
OWN - NLM
STAT- MEDLINE
DCOM- 20101130
LR  - 20111209
IS  - 1879-1379 (Electronic)
IS  - 0022-3956 (Linking)
VI  - 44
IP  - 12
DP  - 2010 Sep
TI  - St. John's wort extract LI160 for the treatment of depression with atypical 
      features - a double-blind, randomized, and placebo-controlled trial.
PG  - 760-7
LID - 10.1016/j.jpsychires.2010.01.010 [doi]
AB  - Preliminary data suggest that hypericum extract LI160 is effective in atypical 
      depression. Reported is the outcome of an 8-week double-blind, 
      placebo-controlled, randomized trial of 600 mg LI160 vs. placebo in patients with 
      vegetative features of atypical depression, i.e. hyperphagia or hypersomnia. 
      One-hundred (100) patients with mild and 100 patients with moderate severity of a 
      major depression according to ICD-10 were randomized. Patients needed to meet a 
      score of 2 in at least one of the items 22-26 of the 
      Hamilton-Depression-Rating-Scale (HAM-D) 28-item version and episode duration of 
      at least 3 months. The primary outcome variable was the relative change of the 
      HAM-D(17) from Baseline. Secondary outcome variables were the depression 
      sub-score of the Patient Health Questionnaire (PHQ-9), the Clinical Global 
      Impression (CGI), a patient's satisfaction scale, the Hamilton-Anxiety-Scale 
      (HAM-A) and the sum score of atypical vegetative symptoms of the HAM-D(28). The 
      percentage reduction of the HAM-D(17) for LI160 compared to placebo approached 
      statistical significance (p=0.051) in the Full Analysis Set (FAS)-population. 
      Using the conventional criterion of the absolute reduction of the HAM-D(17) 
      significance was achieved (p<0.05). No significant benefit could be observed for 
      the sum score of the atypical vegetative items of the HAM-D(28;) however, the sum 
      score of the hypersomnia items (items 22-24) showed a significant superiority for 
      LI160. The HAM-A, PHQ-9, and CGI-I scales demonstrated superiority of LI160 
      (p<0.01). Confining the analysis to moderately depressed patients, a highly 
      significant benefit for the primary outcome variable was revealed. The study 
      supports the beneficial effect of LI160 in depression with atypical features and 
      the validity of the definition of atypical depression on the basis of reversed 
      vegetative signs. Further, it identifies the PHQ-9 as a useful outcome variable 
      in this population.
CI  - Copyright (c) 2010 Elsevier Ltd. All rights reserved.
FAU - Mannel, Marcus
AU  - Mannel M
AD  - Department of Psychosomatic Medicine and Psychotherapy, Campus Benjamin Franklin, 
      Charite Universitatsmedizin Berlin, Germany.
FAU - Kuhn, Ulrike
AU  - Kuhn U
FAU - Schmidt, Ulrich
AU  - Schmidt U
FAU - Ploch, Michael
AU  - Ploch M
FAU - Murck, Harald
AU  - Murck H
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100223
PL  - England
TA  - J Psychiatr Res
JT  - Journal of psychiatric research
JID - 0376331
RN  - 0 (Antidepressive Agents)
RN  - 0 (Hypericum extract LI 160)
RN  - 0 (Plant Extracts)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/*therapeutic use
MH  - Depression/*drug therapy
MH  - Depressive Disorder/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypericum
MH  - Male
MH  - Middle Aged
MH  - Plant Extracts/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Statistics, Nonparametric
MH  - Time Factors
MH  - Young Adult
EDAT- 2010/02/26 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/02/26 06:00
PHST- 2009/08/15 00:00 [received]
PHST- 2010/01/04 00:00 [revised]
PHST- 2010/01/26 00:00 [accepted]
PHST- 2010/02/26 06:00 [entrez]
PHST- 2010/02/26 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - S0022-3956(10)00019-1 [pii]
AID - 10.1016/j.jpsychires.2010.01.010 [doi]
PST - ppublish
SO  - J Psychiatr Res. 2010 Sep;44(12):760-7. doi: 10.1016/j.jpsychires.2010.01.010. 
      Epub 2010 Feb 23.