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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02072278
Other study ID # 15835A
Secondary ID 2013-004015-53
Status Completed
Phase Phase 1
First received February 24, 2014
Last updated August 31, 2015
Start date February 2014

Study information

Verified date November 2014
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Vortioxetine 10 mg

Vortioxetine 20 mg

Escitalopram 15 mg

Placebo


Locations

Country Name City State
France FR801 Rennes

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Battery of EEG measurements 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
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. No
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