Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Men
• Intervention / Treatment: Drug: Placebo; Drug: Vortioxetine 10 mg; Drug: Vortioxetine 20 mg; Drug: Escitalopram 15 mg

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • FR801

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vortioxetine 10 mg; encapsulated tablets; 3 daily doses in each treatment period; orally	Drug: Vortioxetine 10 mg
Experimental: Vortioxetine 20 mg; encapsulated tablets; 3 daily doses in each treatment period; orally	Drug: Vortioxetine 20 mg
Active Comparator: Escitalopram 15 mg; encapsulated tablets; 3 daily doses in each treatment period; orally	Drug: Escitalopram 15 mg
Placebo Comparator: Placebo; capsules; 3 daily doses in each treatment period; orally	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Antidepressive Agents, Second-Generation; Serotonin 5-HT3 Receptor Antagonists; Citalopram; Vortioxetine
• Other Study ID Numbers: 15835A; 2013-004015-53 (EudraCT Number)