Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Men
• Interventions: Drug: Vortioxetine 20 mg; Drug: Vortioxetine 10 mg; Drug: Escitalopram 15 mg; Drug: Placebo

• Registration Number: NCT02072278
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vortioxetine 20 mg	Vortioxetine 20 mg	encapsulated tablets; 3 daily doses in each treatment period; orally
Vortioxetine 10 mg	Vortioxetine 10 mg	encapsulated tablets; 3 daily doses in each treatment period; orally
Escitalopram 15 mg	Escitalopram 15 mg	encapsulated tablets; 3 daily doses in each treatment period; orally
Placebo	Placebo	capsules; 3 daily doses in each treatment period; orally

Primary Outcome Measures

Name	Time	Method
Battery of EEG measurements	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

Trial Locations

Locations (1)

FR801; 🇫🇷 Rennes, France