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

Phase 1CompletedNCT02080715

University of Zurich30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

TolcaponeDRUG

2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)

PlaceboDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Zurich, Institute of Pharmacology and Toxicology

Zurich, Switzerland

Outcomes

Primary Outcomes

Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo

Vigilance is measured subjectively (questionnaires and visual analogue scales) and objectively (e.g., psychomotor vigilance task: reaction times and number of lapses; waking EEG: spectral power) at 3-hour intervals during 40 hours prolonged wakefulness in 30 healthy male adults.

Time frame: Participants will be studied during two weeks

Data from ClinicalTrials.gov

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