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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Zurich, Institute of Pharmacology and Toxicology

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolcapone

Drug

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

Other names: Tasmar

Placebo

Drug

Primary outcomes

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

Time frame: Participants will be studied during two weeks

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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Mar 6, 2014
Registry last updated: Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed