TY - JOUR
T1 - Effects of 12 months of vagus nerve stimulation in treatment-resistant depression
T2 - A naturalistic study
AU - Rush, A. John
AU - Sackeim, Harold A.
AU - Marangell, Lauren B.
AU - George, Mark S.
AU - Brannan, Stephen K.
AU - Davis, Sonia M.
AU - Lavori, Phil
AU - Howland, Robert
AU - Kling, Mitchel A.
AU - Rittberg, Barry
AU - Carpenter, Linda
AU - Ninan, Philip
AU - Moreno, Francisco
AU - Schwartz, Thomas
AU - Conway, Charles
AU - Burke, Michael
AU - Barry, John J.
PY - 2005/9/1
Y1 - 2005/9/1
N2 - Background: The need for effective, long-term treatment for recurrent or chronic, treatment-resistant depression is well established. Methods: This naturalistic follow-up describes outpatients with nonpsychotic major depressive (n = 185) or bipolar (I or II) disorder, depressed phase (n = 20) who initially received 10 weeks of active (n = 110) or sham vagus nerve stimulation (VNS) (n = 95). The initial active group received another 9 months, while the initial sham group received 12 months of VNS. Participants received antidepressant treatments and VNS, both of which could be adjusted. Results: The primary analysis (repeated measures linear regression) revealed a significant reduction in 24-item Hamilton Rating Scale for Depression (HRSD 24) scores (average improvement, .45 points [SE = .05] per month (p < .001). At exit, HRSD 24 response rate was 27.2% (55/202); remission rate (HRSD 24 ≤ 9) was 15.8% (32/202). Montgomery Äsberg Depression Rating Scale (28.2% [57/202]) and Clinical Global Impression-Improvement (34.0% [68/200]) showed similar response rates. Voice alteration, dyspnea, and neck pain were the most frequently reported adverse events. Conclusions: These 1-year open trial data found VNS to be well tolerated, suggesting a potential long-term, growing benefit in treatment-resistant depression, albeit in the context of changes in depression treatments. Comparative long-term data are needed to determine whether these benefits can be attributed to VNS.
AB - Background: The need for effective, long-term treatment for recurrent or chronic, treatment-resistant depression is well established. Methods: This naturalistic follow-up describes outpatients with nonpsychotic major depressive (n = 185) or bipolar (I or II) disorder, depressed phase (n = 20) who initially received 10 weeks of active (n = 110) or sham vagus nerve stimulation (VNS) (n = 95). The initial active group received another 9 months, while the initial sham group received 12 months of VNS. Participants received antidepressant treatments and VNS, both of which could be adjusted. Results: The primary analysis (repeated measures linear regression) revealed a significant reduction in 24-item Hamilton Rating Scale for Depression (HRSD 24) scores (average improvement, .45 points [SE = .05] per month (p < .001). At exit, HRSD 24 response rate was 27.2% (55/202); remission rate (HRSD 24 ≤ 9) was 15.8% (32/202). Montgomery Äsberg Depression Rating Scale (28.2% [57/202]) and Clinical Global Impression-Improvement (34.0% [68/200]) showed similar response rates. Voice alteration, dyspnea, and neck pain were the most frequently reported adverse events. Conclusions: These 1-year open trial data found VNS to be well tolerated, suggesting a potential long-term, growing benefit in treatment-resistant depression, albeit in the context of changes in depression treatments. Comparative long-term data are needed to determine whether these benefits can be attributed to VNS.
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U2 - 10.1016/j.biopsych.2005.05.024
DO - 10.1016/j.biopsych.2005.05.024
M3 - Article
C2 - 16139581
AN - SCOPUS:24044505312
SN - 0006-3223
VL - 58
SP - 355
EP - 363
JO - Biological Psychiatry
JF - Biological Psychiatry
IS - 5
ER -