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Vagus nerve stimulation (VNS) for treatment-resistant depression: efficacy, side effects, and predictors of outcome.

Publication ,  Journal Article
Sackeim, HA; Rush, AJ; George, MS; Marangell, LB; Husain, MM; Nahas, Z; Johnson, CR; Seidman, S; Giller, C; Haines, S; Simpson, RK; Goodman, RR
Published in: Neuropsychopharmacology
November 2001

This open pilot study of vagus nerve stimulation (VNS) in 60 patients with treatment-resistant major depressive episodes (MDEs) aimed to: 1) define the response rate; 2) determine the profile of side effects; and, most importantly; 3) establish predictors of clinical outcome. Participants were outpatients with nonatypical, nonpsychotic, major depressive or bipolar disorder who had not responded to at least two medication trials from different antidepressant classes in the current MDE. While on stable medication regimens, the patients completed a baseline period followed by device implantation. A 2-week, single blind, recovery period (no stimulation) was followed by 10 weeks of VNS. Of 59 completers (one patient improved during the recovery period), the response rate was 30.5% for the primary HRSD(28) measure, 34.0% for the Montgomery-Asberg Depression Rating Scale (MADRAS), and 37.3% for the Clinical Global Impression-Improvement Score (CGI-I of 1 or 2). The most common side effect was voice alteration or hoarseness, 55.0% (33/60), which was generally mild and related to output current intensity. History of treatment resistance was predictive of VNS outcome. Patients who had never received ECT (lifetime) were 3.9 times more likely to respond. Of the 13 patients who had not responded to more than seven adequate antidepressant trials in the current MDE, none responded, compared to 39.1% of the remaining 46 patients (p =.0057). Thus, VNS appears to be most effective in patients with low to moderate, but not extreme, antidepressant resistance. Evidence concerning VNS' long-term therapeutic benefits and tolerability will be critical in determining its role in treatment-resistant depression.

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Published In

Neuropsychopharmacology

DOI

ISSN

0893-133X

Publication Date

November 2001

Volume

25

Issue

5

Start / End Page

713 / 728

Location

England

Related Subject Headings

  • Vagus Nerve
  • Treatment Outcome
  • Quality of Life
  • Psychiatry
  • Psychiatric Status Rating Scales
  • Pilot Projects
  • Mood Disorders
  • Middle Aged
  • Male
  • Humans
 

Citation

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Sackeim, H. A., Rush, A. J., George, M. S., Marangell, L. B., Husain, M. M., Nahas, Z., … Goodman, R. R. (2001). Vagus nerve stimulation (VNS) for treatment-resistant depression: efficacy, side effects, and predictors of outcome. Neuropsychopharmacology, 25(5), 713–728. https://doi.org/10.1016/S0893-133X(01)00271-8
Sackeim, H. A., A. J. Rush, M. S. George, L. B. Marangell, M. M. Husain, Z. Nahas, C. R. Johnson, et al. “Vagus nerve stimulation (VNS) for treatment-resistant depression: efficacy, side effects, and predictors of outcome.Neuropsychopharmacology 25, no. 5 (November 2001): 713–28. https://doi.org/10.1016/S0893-133X(01)00271-8.
Sackeim HA, Rush AJ, George MS, Marangell LB, Husain MM, Nahas Z, et al. Vagus nerve stimulation (VNS) for treatment-resistant depression: efficacy, side effects, and predictors of outcome. Neuropsychopharmacology. 2001 Nov;25(5):713–28.
Sackeim, H. A., et al. “Vagus nerve stimulation (VNS) for treatment-resistant depression: efficacy, side effects, and predictors of outcome.Neuropsychopharmacology, vol. 25, no. 5, Nov. 2001, pp. 713–28. Pubmed, doi:10.1016/S0893-133X(01)00271-8.
Sackeim HA, Rush AJ, George MS, Marangell LB, Husain MM, Nahas Z, Johnson CR, Seidman S, Giller C, Haines S, Simpson RK, Goodman RR. Vagus nerve stimulation (VNS) for treatment-resistant depression: efficacy, side effects, and predictors of outcome. Neuropsychopharmacology. 2001 Nov;25(5):713–728.
Journal cover image

Published In

Neuropsychopharmacology

DOI

ISSN

0893-133X

Publication Date

November 2001

Volume

25

Issue

5

Start / End Page

713 / 728

Location

England

Related Subject Headings

  • Vagus Nerve
  • Treatment Outcome
  • Quality of Life
  • Psychiatry
  • Psychiatric Status Rating Scales
  • Pilot Projects
  • Mood Disorders
  • Middle Aged
  • Male
  • Humans