Abstract
Background: Vagus nerve stimulation has shown promising results in an open, acute
phase pilot study of adults in a treatment-resistant major depressive episode. This
open, naturalistic follow-up study was conducted to determine whether the initial
promising effects were sustained, and whether changes in function would be observed.
Methods: Thirty adult outpatients in a treatment-resistant, nonpsychotic major depressive
episode received an additional 9 months of vagus nerve stimulation treatment following
exit from the 3-month acute study. Changes in psychotropic medications and vagus nerve
stimulation stimulus parameters were allowed during this longer-term follow-up study.
A priori definitions were used to define response (≥ 50% reduction in baseline Hamilton Rating
Scale for Depression total score) and remission (Hamilton Rating Scale for Depression
≤ 10).
Results: The response rate was sustained [40% (12/30) to 46% (13/28); p = .317] and the remission rate significantly increased [17% (5/30) to 29% (8/28);
p = .045] with an additional 9 months of long-term vagus nerve stimulation treatment
after exit from the acute study (1 year total vagus nerve stimulation treatment).
Significant improvements in function between acute study exit and the 1-year follow-up
assessment as measured by the Medical Outcomes Study Short Form-36 were observed.
Conclusions: Longer-term vagus nerve stimulation treatment was associated with sustained
symptomatic benefit and sustained or enhanced functional status in this naturalistic
follow-up study.
Keywords
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Article info
Publication history
Accepted:
November 6,
2001
Received in revised form:
November 2,
2001
Received:
August 13,
2001
Identification
Copyright
© 2002 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
