Background Abecarnil,a novel anxiolytic beta-carboline, was investigat
ed in five four-week double-blind, European multicentre stud ies. Over
all, 451 patients with generalised anxiety disorder were randomised to
abecarnil, 461 to placebo and 464 to active controls. Method Data inc
ludes inferential statistics based on individual studies and descripti
ve analysis of 323 patients in open-label abecarnil long-term continua
tion up to 52 weeks. Results Abecarnil was safe, the most frequent adv
erse event being drowsiness. Onset of effect was at week 1. At week 4
the Hamilton Anxiety Scale score had improved by 12-13 points on avera
ge. Due to notably large and variable placebo effects abecarnil was no
t consistently superior to placebo. No rebound or withdrawal symptoms
were observed after fast-tapered discontinuation. Safety extent of eff
icacy and incidence of rebound or withdrawal did not change during lon
g-term treatment. Conclusions Abecarnil is safe and effective. Further
research into its therapeutic potential seems warranted. Declaration
of interest The author is an employee of Schering AG, Berlin.