Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Vortioxetine 10 mg
- Conditions
- Healthy Men
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Battery of EEG measurements
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
Investigators
Eligibility Criteria
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.
Arms & Interventions
Vortioxetine 10 mg
encapsulated tablets; 3 daily doses in each treatment period; orally
Intervention: Vortioxetine 10 mg
Vortioxetine 20 mg
encapsulated tablets; 3 daily doses in each treatment period; orally
Intervention: Vortioxetine 20 mg
Escitalopram 15 mg
encapsulated tablets; 3 daily doses in each treatment period; orally
Intervention: Escitalopram 15 mg
Placebo
capsules; 3 daily doses in each treatment period; orally
Intervention: Placebo
Outcomes
Primary Outcomes
Battery of EEG measurements
Time Frame: 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