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

doi:10.1016/j.biopsych.2005.05.024

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

Psychiatry & Behavioral Sciences

Research output: Contribution to journal › Article › peer-review

320 Scopus citations

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 language	English (US)
Pages (from-to)	355-363
Number of pages	9
Journal	Biological psychiatry
Volume	58
Issue number	5
DOIs	https://doi.org/10.1016/j.biopsych.2005.05.024
State	Published - Sep 1 2005

Bibliographical note

Funding Information:
This study was supported by Cyberonics, Inc, through contracts to investigational sites. Statistical analyses were conducted by Quintiles Inc. and reviewed by the senior authors. The following principal investigators and sites participated in this study (the approving IRBs are in parentheses): J. Barry, M.D., Stanford University School of Medicine (Stanford University/Human Subjects in Medical Research); M. Burke, M.D., Psychiatric Research Institute (Via Christi) (Via Christi Regional Medical Center Institutional Review Board); W. Burke, University of Nebraska Medical Center (University of Nebraska Institutional Review Board); L. Carpenter, M.D., Brown University/Butler Hospital (Butler Hospital IRB); C. Conway, M.D., St. Louis University Health Science Center (St. Louis University IRB); R. Cooke, M.D., University of Toronto/Centre for Addiction and Mental Health (Centre for Addiction and Mental Health Research Ethics Board); R.A. Dominguez, M.D., University of Miami School of Medicine (University of Miami School of Medicine/Human Subjects Research Office); D. Dunner, M.D., University of Washington Center for Anxiety and Depression (Human Subjects Division, University of Washington); M.S. George, M.D., Medical University of South Carolina (Office of Research Integrity IRB #3); D. Ginsberg, M.D., New York University Medical Center (NYU Medical Center Institutional Board of Research Associates); R. Howland, M.D., University of Pittsburgh School of Medicine (University of Pittsburgh Institutional Review Board); M. Husain, M.D., The University of Texas Southwestern Medical Center (Office of Institutional Review Board U.T. Southwestern Medical Center); M. Kling, M.D., University of Maryland (University of Maryland Baltimore Institutional Review Board); L.B. Marangell, M.D., Baylor College of Medicine (Baylor College of Medicine IRB); F. Moreno, M.D., University of Arizona Health Science Center (Human Subjects Protection Program); A. Nierenberg, M.D., Massachusetts General Hospital (Massachusetts General Hospital IRB); P. Ninan, M.D., Emory University School of Medicine (Emory University Institutional Review Board); B. Rittberg, M.D., University of Minnesota Medical School (Research Subjects’ Protection Program IRB); T. Schwartz, M.D., SUNY Upstate Medical University at Syracuse (State University of New York Upstate Medical University Institutional Review Board); M. Soliman, M.D., University of California San Diego Department of Psychiatry (UCSD Human Research Protection Program); J. Zajecka, M.D., Rush Presbyterian-St. Luke’s Medical Center (Rush University Medical Center IRB).

Keywords

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

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Rush, A. J., Sackeim, H. A., Marangell, L. B., George, M. S., Brannan, S. K., Davis, S. M., Lavori, P., Howland, R., Kling, M. A., Rittberg, B., Carpenter, L., Ninan, P., Moreno, F., Schwartz, T., Conway, C., Burke, 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

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

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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.}",

note = "Funding Information: This study was supported by Cyberonics, Inc, through contracts to investigational sites. Statistical analyses were conducted by Quintiles Inc. and reviewed by the senior authors. The following principal investigators and sites participated in this study (the approving IRBs are in parentheses): J. Barry, M.D., Stanford University School of Medicine (Stanford University/Human Subjects in Medical Research); M. Burke, M.D., Psychiatric Research Institute (Via Christi) (Via Christi Regional Medical Center Institutional Review Board); W. Burke, University of Nebraska Medical Center (University of Nebraska Institutional Review Board); L. Carpenter, M.D., Brown University/Butler Hospital (Butler Hospital IRB); C. Conway, M.D., St. Louis University Health Science Center (St. Louis University IRB); R. Cooke, M.D., University of Toronto/Centre for Addiction and Mental Health (Centre for Addiction and Mental Health Research Ethics Board); R.A. Dominguez, M.D., University of Miami School of Medicine (University of Miami School of Medicine/Human Subjects Research Office); D. Dunner, M.D., University of Washington Center for Anxiety and Depression (Human Subjects Division, University of Washington); M.S. George, M.D., Medical University of South Carolina (Office of Research Integrity IRB #3); D. Ginsberg, M.D., New York University Medical Center (NYU Medical Center Institutional Board of Research Associates); R. Howland, M.D., University of Pittsburgh School of Medicine (University of Pittsburgh Institutional Review Board); M. Husain, M.D., The University of Texas Southwestern Medical Center (Office of Institutional Review Board U.T. Southwestern Medical Center); M. Kling, M.D., University of Maryland (University of Maryland Baltimore Institutional Review Board); L.B. Marangell, M.D., Baylor College of Medicine (Baylor College of Medicine IRB); F. Moreno, M.D., University of Arizona Health Science Center (Human Subjects Protection Program); A. Nierenberg, M.D., Massachusetts General Hospital (Massachusetts General Hospital IRB); P. Ninan, M.D., Emory University School of Medicine (Emory University Institutional Review Board); B. Rittberg, M.D., University of Minnesota Medical School (Research Subjects{\textquoteright} Protection Program IRB); T. Schwartz, M.D., SUNY Upstate Medical University at Syracuse (State University of New York Upstate Medical University Institutional Review Board); M. Soliman, M.D., University of California San Diego Department of Psychiatry (UCSD Human Research Protection Program); J. Zajecka, M.D., Rush Presbyterian-St. Luke{\textquoteright}s Medical Center (Rush University Medical Center IRB). ",

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doi = "10.1016/j.biopsych.2005.05.024",

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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.

N1 - Funding Information: This study was supported by Cyberonics, Inc, through contracts to investigational sites. Statistical analyses were conducted by Quintiles Inc. and reviewed by the senior authors. The following principal investigators and sites participated in this study (the approving IRBs are in parentheses): J. Barry, M.D., Stanford University School of Medicine (Stanford University/Human Subjects in Medical Research); M. Burke, M.D., Psychiatric Research Institute (Via Christi) (Via Christi Regional Medical Center Institutional Review Board); W. Burke, University of Nebraska Medical Center (University of Nebraska Institutional Review Board); L. Carpenter, M.D., Brown University/Butler Hospital (Butler Hospital IRB); C. Conway, M.D., St. Louis University Health Science Center (St. Louis University IRB); R. Cooke, M.D., University of Toronto/Centre for Addiction and Mental Health (Centre for Addiction and Mental Health Research Ethics Board); R.A. Dominguez, M.D., University of Miami School of Medicine (University of Miami School of Medicine/Human Subjects Research Office); D. Dunner, M.D., University of Washington Center for Anxiety and Depression (Human Subjects Division, University of Washington); M.S. George, M.D., Medical University of South Carolina (Office of Research Integrity IRB #3); D. Ginsberg, M.D., New York University Medical Center (NYU Medical Center Institutional Board of Research Associates); R. Howland, M.D., University of Pittsburgh School of Medicine (University of Pittsburgh Institutional Review Board); M. Husain, M.D., The University of Texas Southwestern Medical Center (Office of Institutional Review Board U.T. Southwestern Medical Center); M. Kling, M.D., University of Maryland (University of Maryland Baltimore Institutional Review Board); L.B. Marangell, M.D., Baylor College of Medicine (Baylor College of Medicine IRB); F. Moreno, M.D., University of Arizona Health Science Center (Human Subjects Protection Program); A. Nierenberg, M.D., Massachusetts General Hospital (Massachusetts General Hospital IRB); P. Ninan, M.D., Emory University School of Medicine (Emory University Institutional Review Board); B. Rittberg, M.D., University of Minnesota Medical School (Research Subjects’ Protection Program IRB); T. Schwartz, M.D., SUNY Upstate Medical University at Syracuse (State University of New York Upstate Medical University Institutional Review Board); M. Soliman, M.D., University of California San Diego Department of Psychiatry (UCSD Human Research Protection Program); J. Zajecka, M.D., Rush Presbyterian-St. Luke’s Medical Center (Rush University Medical Center IRB).

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)

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

Abstract

Bibliographical note

Keywords

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