Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

Healthy Men Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072278
• Other study ID #: 15835A
• Secondary ID: 2013-004015-53
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2014
• Last updated: August 31, 2015
• Start date: February 2014

Study information

• Verified date: November 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Men

Intervention

Drug:
• Vortioxetine 10 mg

• Vortioxetine 20 mg

• Escitalopram 15 mg

• Placebo

Locations

Country	Name	City	State
France	FR801	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	No