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

University of Zurich (UZH)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Tolcapone

Study type: Interventional

Funder types: Other

Identifiers

NCT02080715

COMT and vigilance

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 20 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 1 patient group

Tolcapone

Experimental group

Description:

Tasmar

Treatment:

Drug: Placebo

Drug: Tolcapone