Is it possible to evaluate true prophylactic efficacy of antidepressants in severely ill patients with recurrent depression? Lessons from a placebo-controlled trial. The fifth trial of the Danish University Antidepressant Group (DUAG-5)

2013 ◽  
Vol 148 (2-3) ◽  
pp. 286-290 ◽  
Author(s):  
Rasmus W. Licht
2017 ◽  
Vol 86 (4) ◽  
pp. 220-230 ◽  
Author(s):  
Karolien E.M. Biesheuvel-Leliefeld ◽  
Sandra M.A. Dijkstra-Kersten ◽  
Digna J.F. van Schaik ◽  
Harm W.J. van Marwijk ◽  
Filip Smit ◽  
...  

1981 ◽  
Author(s):  
R von Hugo ◽  
R Hafter ◽  
H Graeff

The frequency of thrombosis (D.V.T.) in patients treated for gynaecological cancer by combined external irradation and intravaginal radium application, as detected by the 125 I-fibrinogen-test, is considerable (43 % D.V.T.).84 patients undergoing radiotherapy were studied in a first controlled trial to assess the effect of 2×7500 U daily s.c. calcium heparin and 2×5000 U daily s.c. of a semisynthetic heparin analogue (SSHA) on the incidence of D.V.T. during therapy. 4 patients had to be excluded. The frequence of D.V.T. was 15 % (6/40) in the heparin group and 25 % (10/40) in the SSHA group. The difference was not statistically significant.Long term application of prophylaxis (regular radiotherapy lasts 4 weeks) causes discomfort to the patient because of the numerous subcutaneous injections.lt was the aim of a second trial to investigate the prophylactic efficacy of a single s.c. injection per day.80 patients were randomly allocated into two groups and received either 12500 U calcium heparin (n=40) or 12500 U SSHA (n=40). The incidence of D.V.T. was reduced to 15 % by a single heparin injection per day; in patients given SSHA the incidence was 17,5 %.The results presented indicate that SSHA is as effective as heparin in preventing D.V.T. during radiotherapy and that a single s.c. injection per day is sufficient.


2007 ◽  
Vol 22 (4) ◽  
pp. 252-255 ◽  
Author(s):  
Y. Lecrubier ◽  
P. Bech

AbstractObjectiveUsing the data of a positive d.b.c.t. comparing an hypericum extract (W55570) to placebo in depressed patients we explored whether the Ham D6 was unidimentional and in case of a positive answer whether the total score was as sensitive as the total score of the Ham D17.MethodsThe study was a 6 weeks double blind placebo controlled trial comparing 300 mg of hypericum t.i.d (n = 186), to placebo (n = 189), in patients with a single or recurrent depression according to DSM-IV. Superiority of hypericum versus placebo on the main outcome criterion (HDRS 17) was already published.The unidimensionality of the Hamilton depression scale 6 and 17 items were tested using a Mokken scale analysis. The effect size according to the initial severity of depression was calculated on the ITT last observation carried forward population.ResultsThe Ham D6, covering the core symptoms of depression was unidimensional, implying that improving this score reflects a true antidepressant effect. The Ham D17 was not unidimensional.Hypericum was an effective antidepressant in patients with a pre-treatment score of 12 or more (n = 208) on the Ham D6, the effect size was 0.46. No difference with placebo was observed for those with a score of less than 12 (n = 167).ConclusionsFor the evaluation of an antidepressant effect, because of its specificity and sensitivity, the Ham D6 should be used as a primary outcome measure rather than the Ham D17.


2005 ◽  
Vol 73 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Claudi L. H. Bockting ◽  
◽  
Aart H. Schene ◽  
Philip Spinhoven ◽  
Maarten W. J. Koeter ◽  
...  

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208570 ◽  
Author(s):  
Karolien E. M. Biesheuvel-Leliefeld ◽  
Judith E. Bosmans ◽  
Sandra M. A. Dijkstra-Kersten ◽  
Filip Smit ◽  
Claudi L. H. Bockting ◽  
...  

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