TREATMENT OF THE ALCOHOLIC ORGANIC BRAIN-SYNDROME - DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL, PSYCHOMETRIC AND ELECTROENCEPHALOGRAPHIC MAPPING STUDIES WITH MODAFINIL

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.