EUCTR2018‐003464‐32‐HU.

Study name	Effect of mirtazapine on seizure frequency in epileptic patients with vagal nerve stimulation device
Methods	Double‐blind, randomised, placebo controlled trial
Participants	Target sample size 30 participants Adults (18 to 65 years ) with drug resistant epilepsy with focal seizures, with or without loss of consciousness, and a vagal nerve stimulation device implanted and activated > 6 months prior to enrolment
Interventions	Mirtazapine (30 mg) compared to placebo
Outcomes	Change in seizure frequency at weeks 12 and 27 Quality of Life: using the self‐administered Quality of Life in Epilepsy 89 (QOLIE‐89) at weeks 12, 15, and 27 Depression: using Beck Depression Inventory (BDI), and Hamilton Depression Rating Scale (HAM‐D) at weeks 12, 15, and 27
Starting date	08 /11/2019
Contact information	None provided
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