Healthy Men
Conditions
Brief summary
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
Interventions
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Battery of EEG measurements | 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 |
Countries
France
Outcome results
None listed