Vagus nerve stimulation (VNS) has gained increasing acceptance for treatmen
t of drug-resistant seizures. The aim of this study was to evaluate effects
of VNS on depressed mood in epilepsy patients during the first 6 months af
ter implantation of the stimulation device. This study was conducted as an
addition to the international multisite randomized and double-blind control
led trial on anti-seizure effects of VNS (EO3). Only adult patients with >
4/month medication-resistant complex-partial seizures were included (N = 11
). During the acute phase of the study (3 months after implantation), patie
nts were randomly assigned to low (stimulation detection) versus high stimu
lation (maximal tolerability, maximum 1.75 mA). Mood and mood changes were
recorded based on standardized psychiatric rating scales and self-report qu
estionnaires. Patients were assessed 4 weeks before (baseline) as well as 3
and 6 months after implantation. Significant positive mood effects were ob
served in most scales and subscales at the 3-month follow-up (P < 0.05). Mo
od improvements were sustained at the 6-month follow-up and were independen
t of effects on seizure activity (9/11 mood responders versus 2/11 seizure
responders). Mood effects appeared more pronounced in the high stimulation
group after the acute study phase, but findings were not significant (P < 0
.10). VNS is associated with mood improvements in patients with epilepsy, b
ut to confirm VNS dose effects, studies with more statistical power are nee
ded. (C) 2000 Elsevier Science B.V. All rights reserved.