Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

NCT ID: NCT02072278

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

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

Detailed Description

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Conditions

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Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vortioxetine 10 mg

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

Group Type EXPERIMENTAL

Vortioxetine 10 mg

Intervention Type DRUG

Vortioxetine 20 mg

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

Group Type EXPERIMENTAL

Vortioxetine 20 mg

Intervention Type DRUG

Escitalopram 15 mg

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

Group Type ACTIVE_COMPARATOR

Escitalopram 15 mg

Intervention Type DRUG

Placebo

capsules; 3 daily doses in each treatment period; orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vortioxetine 10 mg

Intervention Type DRUG

Vortioxetine 20 mg

Intervention Type DRUG

Escitalopram 15 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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FR801

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2013-004015-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15835A

Identifier Type: -

Identifier Source: org_study_id

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