Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance

A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation

In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are identified by measurement of vigilance and cognitive performance as well as EEG measurements during wake and sleep.

• Trial with medicinal product

Inclusion criteria:

• Healthy male subjects
• Age: 20-30 years
• written informed consent
• right handed
• non smoker

Exclusion criteria:

• sleep disturbances
• irregular sleep-wake rhythm
• travelling with time-shift
• liver diseases (ALT: > 82 U/l; AST: > 76 U/l)
• diseases of the nervous system
• acute internal medicine diseases
• medication or drug abuse
• intake of more than 3 caffeine-containing drinks
• intake of more than 5 alcoholic drinks per week
• heart pacemaker or implanted medical devices
• Body-Mass-Index (BMI): 20< BMI >26