Vagus nerve stimulation significantly decreased Beck Depression Inventory scores from a baseline mean of 37.8 to 24.6 at 12 months (P<0.01) in patients with treatment-resistant depression.
Observational (n=15)
Does vagus nerve stimulation improve depression scores in outpatients with treatment-resistant major depressive episodes?
Vagus nerve stimulation significantly improved depression scores at 12 months in a real-world clinical practice setting for patients with treatment-resistant major depression.
Absolute Event Rate: 24.6% vs 37.8%
p-value: p=<.01
Article AbstractObjective: To describe the outcomes of a consecutive series of depressed patients treated with vagus nerve stimulation (VNS) following US Food and Drug Administration (FDA) approval of this intervention. Method: We implanted a VNS device in 15 consecutive outpatients with treatment-resistant major depressive episodes, including 10 with major depressive disorder and 5 with bipolar disorder (DSM-IV criteria), between November 2005 and August 2006. Existing antidepressant treatment remained fixed as far as clinically possible. The primary outcome was change from baseline in the Beck Depression Inventory (BDI) score. Outcomes were assessed at 6 and 12 months postimplant and compared to those of the VNS pivotal efficacy trial that led to FDA approval of VNS. Results: The BDI score decreased significantly compared to baseline at 6 months (P < .05) and 12 months (P < .01), from a mean of 37.8 (SD = 7.8) before VNS activation to a mean of 24.6 (SD = 11.4) at 12 months. By 1 year, 28.6% (n = 4) of the sample responded to VNS and 7.1% (n = 1) remitted according to the BDI. Secondary outcomes on the Hamilton Depression Rating Scale 24-Item showed similar improvement at 1 year, with a 43% response rate (n = 6) and 14.3% remission rate (n = 2). No obvious predictors of response were detected. Side effects of VNS included hoarseness (73%), dyspnea (47%), nausea (40%), pain (33%), and anxiety (20%); no patient terminated treatment due to intolerable side effects. Conclusions: We found that a substantial minority of patients with extremely difficult-to-treat depressive disorders benefited from VNS in an ambulatory clinical practice, with outcomes comparable to those observed in previous VNS efficacy studies and with a similar side effect profile. J Clin Psychiatry Submitted: December 7, 2009; accepted April 7, 2010. Online ahead of print: January 11, 2011 (doi:10.4088/JCP.09m05888blu). Corresponding author: Pilar Cristancho, MD, Mood and Anxiety Disorders Treatment and Research Program, University of Pennsylvania School of Medicine, 3535 Market St, Ste 4002, Philadelphia, PA 19104 (pilar.cristancho@uphs.upenn.edu).
Cristancho et al. (Thu,) conducted a observational in Treatment-resistant major depressive episodes (n=15). Vagus nerve stimulation vs. Baseline was evaluated on Change from baseline in the Beck Depression Inventory (BDI) score (p=<.01). Vagus nerve stimulation significantly decreased Beck Depression Inventory scores from a baseline mean of 37.8 to 24.6 at 12 months (P<0.01) in patients with treatment-resistant depression.