Original articleA One-Year Comparison of Vagus Nerve Stimulation with Treatment as Usual for Treatment-Resistant Depression
Section snippets
Methods and Materials
Table 1 lists similarities and differences between the VNS+TAU and TAU studies. Treatment resistance for both the TAU and VNS+TAU studies was defined for the current MDE with a modified Antidepressant Treatment History Form (ATHF) (Oquendo et al 1999, Prudic et al 1990, Prudic et al 1996, Sackeim 2001a, Sackeim et al 1990, Sackeim et al 2000).
The TAU group was studied at 13 sites, 12 of which had participated in the VNS+TAU study. An additional 9 sites participated only in the VNS+TAU study.
Results
Table 2 presents the clinical and demographic features of the two evaluable samples (VNS+TAU, n = 205; TAU, n = 124). The VNS+TAU evaluable 12-month sample (Rush et al 2005b) excluded 3 participants who did not meet continuation criteria, 4 who had no long-term assessments, and 21 sham-control participants whose new baseline HRSD24 score at stimulation initiation was below the cutoff of ≥18. The TAU evaluable sample excluded three participants who did not provide data after the baseline
Discussion
This study compared two nonrandomized but similar groups of treatment-resistant depressed outpatients who received VNS+TAU or TAU alone over 12 months of treatment. The two groups were comparable in terms of baseline features. The primary analysis found a significant between-group difference favoring VNS+TAU over TAU alone that grew over time. Results were positive with and without propensity adjustments.
In addition, multiple secondary analyses found clinically important differences between the
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