TREATMENT OF THE ALCOHOLIC ORGANIC BRAIN-SYNDROME - DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL, PSYCHOMETRIC AND ELECTROENCEPHALOGRAPHIC MAPPING STUDIES WITH MODAFINIL
B. Saletu et al., TREATMENT OF THE ALCOHOLIC ORGANIC BRAIN-SYNDROME - DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL, PSYCHOMETRIC AND ELECTROENCEPHALOGRAPHIC MAPPING STUDIES WITH MODAFINIL, Neuropsychobiology, 27(1), 1993, pp. 26-39
In a double-blind study 40 abstinent hospitalized male patients with a
n alcoholic organic brain syndrome (OBS; ICD 9: 291.2) were treated fo
r 6 weeks with either placebo or 200 mg modafinil b.i.d. Modafinil (CR
L 40476) is a vigilance-promoting, putative central alpha1-adrenergic
agonist with a pharmacological profile quite different from that of am
phetamine. Clinical investigations demonstrated that the spontaneous r
emission of the alcoholic OBS was augmented and accelerated by modafin
il, which was found significant as compared with placebo by confirmato
ry statistics in the target variable, the Clinical Global Impression s
cale. The drug was well tolerated. Psychometric tests revealed signifi
cant improvement of the noopsyche after modafinil as compared with pla
cebo, while the thymopsyche and psychophysiological measurements were
not affected. Electroencephalographic mapping showed significant diffe
rences between the central effects of modafinil and placebo indicating
an improvement of vigilance under modafinil. Typical vigilance-promot
ing properties were seen after acute drug administration, were less ev
ident before the morning dose after chronic treatment but re-occurred
after superimposed daily drug administration. Thus, our clinical, psyc
hometric and neurophysiological investigations in alcoholic OBS patien
ts demonstrated a therapeutic effect of modafinil in the early phase o
f abstinence.