A multicenter, double-blind, controlled study of pivagabine (4-[(2,2-d
imethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg(R)) wa
s conducted in 186 female patients (age: 33-79 years) suffering from c
limacteric syndrome. In these patients, climacteric syndrome was mainl
y constitued by symptoms of anxiety, often with mild symptoms of depre
ssion and sometimes with mild symptoms of cardiac somatization. The en
rolled patients were randomized to two treatment groups: the first gro
up was administered pivagabine, 900 mg/d, fcr 90 days in succession; t
he second group was administered placebo for the same period. The effi
cacy of the treatments was assessed by the Hamilton Depression Rating
Scale (HDRS) and the Zung's Self-rating Anxiety Scale (SAS) before the
start of treatment, after one month and at the end of treatment. At t
he end of the study, the physicians and the patients were also request
ed to evaluate the efficacy of the two treatments. Tolerability was ev
aluated by recording side effects and by assessing the course of arter
ial blood pressure, of heart rate and of selected laboratory parameter
s. The study showed that pivagabine was able to reduce symptoms of anx
iety and depression. As a consequence, when asked to evalulate the eff
icacy, the physicians and the patients consistently stated that pivaga
bine was effective in controlling the symptoms of anxiety, often assoc
iated with mild symptoms of depression, that may arise during the clim
acterium. Furthermore, these results were obtained with a high safety
margin, since the few side effects recorded were mild and transient an
d the laboratory results were normal as well as the physical examinati
on findings.