Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: A naturalistic study

A. John Rush, Harold A. Sackeim, Lauren B. Marangell, Mark S. George, Stephen K. Brannan, Sonia M. Davis, Phil Lavori, Robert Howland, Mitchel A. Kling, Barry Rittberg, Linda Carpenter, Philip Ninan, Francisco Moreno, Thomas Schwartz, Charles Conway, Michael Burke, John J. Barry

Research output: Contribution to journalArticle

243 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)355-363
Number of pages9
JournalBiological Psychiatry
Volume58
Issue number5
DOIs
StatePublished - Sep 1 2005

Fingerprint

Treatment-Resistant Depressive Disorder
Vagus Nerve Stimulation
Depression
Neck Pain
Dyspnea
Antidepressive Agents
Linear Models
Outpatients
Therapeutics

Keywords

  • Clinical trial
  • Efficacy
  • Major depressive disorder, Bipolar disorder
  • Side effects
  • Treatment-resistant depression (TRD)
  • Vagus nerve stimulation (VNS)

ASJC Scopus subject areas

  • Biological Psychiatry

Cite this

Rush, A. J., Sackeim, H. A., Marangell, L. B., George, M. S., Brannan, S. K., Davis, S. M., ... Barry, J. J. (2005). Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: A naturalistic study. Biological Psychiatry, 58(5), 355-363. https://doi.org/10.1016/j.biopsych.2005.05.024

Effects of 12 months of vagus nerve stimulation in treatment-resistant depression : A naturalistic study. / Rush, A. John; Sackeim, Harold A.; Marangell, Lauren B.; George, Mark S.; Brannan, Stephen K.; Davis, Sonia M.; Lavori, Phil; Howland, Robert; Kling, Mitchel A.; Rittberg, Barry; Carpenter, Linda; Ninan, Philip; Moreno, Francisco; Schwartz, Thomas; Conway, Charles; Burke, Michael; Barry, John J.

In: Biological Psychiatry, Vol. 58, No. 5, 01.09.2005, p. 355-363.

Research output: Contribution to journalArticle

Rush, AJ, Sackeim, HA, Marangell, LB, George, MS, Brannan, SK, Davis, SM, Lavori, P, Howland, R, Kling, MA, Rittberg, B, Carpenter, L, Ninan, P, Moreno, F, Schwartz, T, Conway, C, Burke, M & Barry, JJ 2005, 'Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: A naturalistic study', Biological Psychiatry, vol. 58, no. 5, pp. 355-363. https://doi.org/10.1016/j.biopsych.2005.05.024
Rush, A. John ; Sackeim, Harold A. ; Marangell, Lauren B. ; George, Mark S. ; Brannan, Stephen K. ; Davis, Sonia M. ; Lavori, Phil ; Howland, Robert ; Kling, Mitchel A. ; Rittberg, Barry ; Carpenter, Linda ; Ninan, Philip ; Moreno, Francisco ; Schwartz, Thomas ; Conway, Charles ; Burke, Michael ; Barry, John J. / Effects of 12 months of vagus nerve stimulation in treatment-resistant depression : A naturalistic study. In: Biological Psychiatry. 2005 ; Vol. 58, No. 5. pp. 355-363.
@article{eb7cb6467515418dabf36f913f3b5174,
title = "Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: A naturalistic study",
abstract = "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 {\"A}sberg 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.",
keywords = "Clinical trial, Efficacy, Major depressive disorder, Bipolar disorder, Side effects, Treatment-resistant depression (TRD), Vagus nerve stimulation (VNS)",
author = "Rush, {A. John} and Sackeim, {Harold A.} and Marangell, {Lauren B.} and George, {Mark S.} and Brannan, {Stephen K.} and Davis, {Sonia M.} and Phil Lavori and Robert Howland and Kling, {Mitchel A.} and Barry Rittberg and Linda Carpenter and Philip Ninan and Francisco Moreno and Thomas Schwartz and Charles Conway and Michael Burke and Barry, {John J.}",
year = "2005",
month = "9",
day = "1",
doi = "10.1016/j.biopsych.2005.05.024",
language = "English (US)",
volume = "58",
pages = "355--363",
journal = "Biological Psychiatry",
issn = "0006-3223",
publisher = "Elsevier USA",
number = "5",

}

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.

KW - Clinical trial

KW - Efficacy

KW - Major depressive disorder, Bipolar disorder

KW - Side effects

KW - Treatment-resistant depression (TRD)

KW - Vagus nerve stimulation (VNS)

UR - http://www.scopus.com/inward/record.url?scp=24044505312&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=24044505312&partnerID=8YFLogxK

U2 - 10.1016/j.biopsych.2005.05.024

DO - 10.1016/j.biopsych.2005.05.024

M3 - Article

C2 - 16139581

AN - SCOPUS:24044505312

VL - 58

SP - 355

EP - 363

JO - Biological Psychiatry

JF - Biological Psychiatry

SN - 0006-3223

IS - 5

ER -