Original articleEffects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study
Section snippets
Study Overview
For entry into this naturalistic phase, participants had to have completed the acute phase randomized comparison of sham versus active VNS (10 weeks of either sham or active VNS delivered after 2 weeks of recovery from device implantation) (Rush et al 2000, Rush et al 2003, Rush et al 2004a, Rush et al 1996, Rush et al 2002, Rush et al 2004b, Rush et al 2005). The IRB approvals and informed consents obtained at the beginning of the 12-week acute study (Rush et al 2000, Rush et al 2003, Rush et
Sample Development
The evaluable (n = 205) sample was developed from the implanted/randomized sample (n = 235). Of these 235 participants, two participants were not included in this analysis of the 12-month outcomes (one because of suicide during the acute phase; one because of device explantation secondary to infection during the acute phase). The remaining 233 participants formed the 12-month safety sample.
Of these 233 participants, 28 were not evaluable for efficacy. Three participants had HRSD24 scores <18
Discussion
This 12-month study (n = 205) of VNS used as an adjunct to other antidepressant treatments in patients with treatment-resistant, chronic or recurrent mood disorders revealed statistically significant reductions in depressive symptoms. The primary repeated measures linear regression analysis of the evaluable sample revealed a statistically significant reduction over time in both the HRSD24 total scores and the IDS-SR30 total scores.
The clinical relevance of the symptom reduction was demonstrated
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