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OpenTrials
Completed

NCT Number: NCT02072278

Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine

Completed

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Key information

Conditions

Healthy Men

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

FR801

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject has a normal resting EEG at screening visit
  • The subject is able to perform tasks with an auditory stimulus
  • The subject is not visually impaired - normal prescription glasses are accepted
  • The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.

Exclusion criteria

  • The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.

Other inclusion and exclusion criteria may apply.

Treatment and study plan

Vortioxetine 10 mg

Drug

Vortioxetine 20 mg

Drug

Escitalopram 15 mg

Drug

Placebo

Drug

Primary outcomes

  1. Battery of EEG measurements

    Time frame: The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period.

    • Peak amplitude and latency of P300
    • AUC of qEEG power spectral bands delta, theta, alpha, beta and gamma
    • AUC of evoked gamma power spectral band
    • Peak amplitude and latency of N200
    • Peak amplitude and latency of error related negativity
    • Peak amplitudes and latencies in the evoked responses during successful versus non-successful encoding in the verbal memory task between treatments

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
First posted
Feb 26, 2014
Registry last updated
Sep 1, 2015

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.

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