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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tolcapone

Tasmar

Group Type EXPERIMENTAL

Tolcapone

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Interventions

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Tolcapone

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Tasmar

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No