Jd. Bremner et Wt. Smith, ORG-3770 VS AMITRIPTYLINE IN THE CONTINUATION TREATMENT OF DEPRESSION- A PLACEBO-CONTROLLED TRIAL, The European journal of psychiatry, 10(1), 1996, pp. 5-15
One hundred and eighteen patients who participated in two short-term d
ouble-blind comparisons of Org 3770, amitriptyline and placebo were su
bsequently included into a 20-week extension trial. Data is presented
from the extension trial. Lack of efficacy was the main reason for pat
ient withdrawal in the placebo group, while adverse effects were so in
both active-treatment groups. The Org 3770-treated group had the most
favorable outcome: the mean group HAMD score remained less than or eq
ual to 7 and CGI-Severity of Illness score less than or equal to 2. On
ly 2.4% Org 3770 patients had an endpoint HAMD score greater than or e
qual to 16. In the amitriptyline-treated group, the mean HAMD score st
abilized at level less than or equal to 7 at week 12, with 10.4% patie
nts having an endpoint HAMD score greater than or equal to 16. The mea
n HAMD score of the placebo group remained greater than or equal to 7
throughout the trial, with 23.0% patients having an endpoint HAMD scor
e greater than or equal to 16. Org 3770 was tolerated well, and advers
e effects were present in substantially fewer patients than in the ami
triptyline group.