Abstract
Background
Transcranial magnetic stimulation (TMS) is a safe and effective treatment for major
depression. We describe quality of life (QOL) outcomes from acute treatment with TMS,
and describe the durability of benefit across 24-weeks.
Methods
Three hundred and one medication-free patients with pharmacoresistant major depression
were randomized to active or sham TMS in a 6-week controlled trial. Nonresponders
to the 6-week blinded phase of the study were enrolled in a 6-week open-label study
without unblinding the prior treatment assignment. Responders and partial responders
to both the blinded (active or sham treatment) or open acute treatment phases were
tapered off TMS over three weeks, while initiating maintenance antidepressant medication
monotherapy. These subjects entered the 24-week study to examine the durability of
response to TMS. The Medical Outcomes Study-36 Item Short Form (SF-36) and the Quality
of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) were used to measure overall
function and QOL. During the 24-week durability of effect study, QOL assessments were
done at study entry and at the end of 24-weeks.
Results
Statistically significant improvement in both functional status and QOL outcomes was
observed in patients treated with active TMS compared with sham TMS during the acute
phase of the randomized, sham-controlled trial. Similar benefits were observed in
patients who entered the open-label extension study. These improvements were sustained
across the 24-week follow up study.
Conclusions
Acute treatment with TMS improved functional status and QOL outcomes in patients with
major depression. This clinical effect was durable in long-term follow up.
Keywords
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Article info
Publication history
Published online: November 06, 2013
Accepted:
October 25,
2013
Received in revised form:
October 10,
2013
Received:
May 13,
2013
Footnotes
Clinical trial posted on www.clinicaltrials.gov. Listing No. NCT 00104611. Supported by a grant from Neuronetics Inc.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.