Randomised, double-blind, placebo-controlled study of pivagabine in neurasthenia.
One hundred and eighteen patients with neurasthenia, as defined by ICD 10 (International Classification of Diseases), participated in a randomised, double-blind, placebo-controlled trial of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg). Pivagabine 1800 mg/d was administered orally for four weeks. At the end of the trial, active medication was significantly superior to placebo on the Clinical Global Impression (CGI) improvement of illness scale. In addition, pivagabine treatment reduced the physical and mental fatigability of patients, and increased their sense of well-being.
Pizzolato
G
G
Clinica Neurologica dell'Università di Padova, Italy.
Cagnin
A
A
Mancia
D
D
Caffarra
P
P
Avanzi
S
S
Copelli
S
S
Ciappina
C
C
Lo Presti
F
F
Spilimbergo
P G
PG
D'Antonio
E
E
Di Costanzo
E
E
Matrango
M
M
Pastres
P
P
Urbani
P P
PP
Signorino
M
M
Simoncelli
M
M
Provinciali
L
L
Regnicolo
L
L
Albano
C
C
Roccatagliata
G
G
Rubino
V
V
Cultrera
S
S
Fracassi
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009440:Neurasthenia / Q000188:drug therapy* / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D011619:Psychotropic Drugs; D005680:gamma-Aminobutyric Acid; C038979:pivagabine