Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

NCT02072278 | Completed Phase 1

• 2 other identifiers: 15835A2013-004015-53
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Vortioxetine 10 mg

EXPERIMENTAL

encapsulated tablets; 3 daily doses in each treatment period; orally

Drug: Vortioxetine 10 mg

Vortioxetine 20 mg

EXPERIMENTAL

encapsulated tablets; 3 daily doses in each treatment period; orally

Drug: Vortioxetine 20 mg

Escitalopram 15 mg

ACTIVE COMPARATOR

encapsulated tablets; 3 daily doses in each treatment period; orally

Drug: Escitalopram 15 mg

Placebo

PLACEBO COMPARATOR

capsules; 3 daily doses in each treatment period; orally

Drug: Placebo

Interventions

Vortioxetine 10 mg DRUG

Vortioxetine 10 mg

Vortioxetine 20 mg DRUG

Vortioxetine 20 mg

Escitalopram 15 mg DRUG

Escitalopram 15 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

FR801

Rennes, 35000, France

Location

MeSH Terms

Interventions

Vortioxetine; Escitalopram

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2014-11

Locations

FR (1)