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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tolcapone; Drug: Placebo

• Registration Number: NCT02080715
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tolcapone	Placebo	Tasmar
Tolcapone	Tolcapone	Tasmar

Primary Outcome Measures

Name	Time	Method
Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo	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.

Trial Locations

Locations (1)

University of Zurich, Institute of Pharmacology and Toxicology; 🇨🇭 Zurich, Switzerland