Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Men

Treatments: Drug: Escitalopram 15 mg; Drug: Placebo; Drug: Vortioxetine 10 mg; Drug: Vortioxetine 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072278

2013-004015-53 (EudraCT Number)

15835A

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

32 participants in 4 patient groups, including a placebo group

Vortioxetine 10 mg

Experimental group

Description:

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

Treatment:

Drug: Vortioxetine 10 mg

Vortioxetine 20 mg

Experimental group

Description:

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

Treatment:

Drug: Vortioxetine 20 mg

Escitalopram 15 mg

Active Comparator group

Description:

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

Treatment:

Drug: Escitalopram 15 mg

Placebo

Placebo Comparator group

Description:

capsules; 3 daily doses in each treatment period; orally

Treatment:

Drug: Placebo