Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

Phase 1CompletedNCT02072278

H. Lundbeck A/S32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Men

Interventions

Vortioxetine 10 mgDRUG

Vortioxetine 20 mgDRUG

Escitalopram 15 mgDRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

FR801

Rennes, France

Outcomes

Primary Outcomes

Battery of EEG measurements

* 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

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.

Data from ClinicalTrials.gov

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