Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- The subject is able to perform tasks with an auditory stimulus
- 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.
- The subject has a normal resting EEG at screening visit
- ...
- The subject is able to perform tasks with an auditory stimulus
- 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.
- The subject has a normal resting EEG at screening visit
- The subject is not visually impaired - normal prescription glasses are accepted
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.
- The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
Summary
- Conditions
- Healthy Men
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Inclusion Criteria
- The subject is able to perform tasks with an auditory stimulus
- 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.
- The subject has a normal resting EEG at screening visit
- ...
- The subject is able to perform tasks with an auditory stimulus
- 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.
- The subject has a normal resting EEG at screening visit
- The subject is not visually impaired - normal prescription glasses are accepted
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.
- The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
Tracking Information
- NCT #
- NCT02072278
- Collaborators
- Not Provided
- Investigators
- Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
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