A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality.

Abstract

OBJECTIVE:

The Treatment-Resistant Depression Registry investigated whether adjunctive vagus nerve stimulation (VNS) with treatment as usual in depression has superior long-term outcomes compared with treatment as usual only.

METHOD:

This 5-year, prospective, open-label, nonrandomized, observational registry study was conducted at 61 U.S. sites and included 795 patients who were experiencing a major depressive episode (unipolar or bipolar depression) of at least 2 years' duration or had three or more depressive episodes (including the current episode), and who had failed four or more depression treatments (including ECT). Patients with a history of psychosis or rapid-cycling bipolar disorder were excluded. The primary efficacy measure was response rate, defined as a decrease of ≥50% in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score at any postbaseline visit during the 5-year study. Secondary efficacy measures included remission.

RESULTS:

Patients had chronic moderate to severe depression at baseline (the mean MADRS score was 29.3 [SD=6.9] for the treatment-as-usual group and 33.1 [SD=7.0] for the adjunctive VNS group). The registry results indicate that the adjunctive VNS group had better clinical outcomes than the treatment-as-usual group, including a significantly higher 5-year cumulative response rate (67.6% compared with 40.9%) and a significantly higher remission rate (cumulative first-time remitters, 43.3% compared with 25.7%). A subanalysis demonstrated that among patients with a history of response to ECT, those in the adjunctive VNS group had a significantly higher 5-year cumulative response rate than those in the treatment-as-usual group (71.3% compared with 56.9%). A similar significant response differential was observed among ECT nonresponders (59.6% compared with 34.1%).

CONCLUSIONS:

This registry represents the longest and largest naturalistic study of efficacy outcomes in treatment-resistant depression, and it provides additional evidence that adjunctive VNS has enhanced antidepressant effects compared with treatment as usual in this severely ill patient population.

• Authors: Scott T Aaronson, Peter Sears, Francis Ruvuna, Mark Bunker, Charles R Conway, Darin D Dougherty, Frederick W Reimherr, Thomas L Schwartz, John M Zajecka
• Journal: The American journal of psychiatry (Am J Psychiatry) Vol. 174 Issue 7 Pg. 640-648 (07 01 2017) ISSN: 1535-7228 [Electronic] United States
• PMID: 28359201 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Bipolar Disorder (diagnosis, psychology, therapy)
• Chronic Disease
• Depressive Disorder, Major (diagnosis, psychology, therapy)
• Depressive Disorder, Treatment-Resistant (diagnosis, psychology, therapy)
• Electroconvulsive Therapy
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Prospective Studies
• Registries
• Suicidal Ideation
• Treatment Outcome
• Vagus Nerve Stimulation (methods)