期刊
AMERICAN JOURNAL OF PSYCHIATRY
卷 174, 期 7, 页码 640-648出版社
AMER PSYCHIATRIC PUBLISHING, INC
DOI: 10.1176/appi.ajp.2017.16010034
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资金
- Cyberonics, Inc.
- Neuronetics
- Dalio Foundation
- Stanley Medical Research Institute
- August Busch IV Foundation
- Barnes-Jewish Hospital Foundation
- Brain and Behavior Research Foundation
- Bristol-Myers Squibb
- NeoSync
- NIMH
- Sidney R. Baer, Jr., Foundation
- Stanley Foundation
- Taylor Family Institute for Innovative Psychiatric Research
- Washington University Center for Brain Research in Mood Disorders
- Cyberonics
- Eli Lilly
- Forest Laboratories
- Medtronic
- Roche
- Actavis
- Alkermes
- AstraZeneca
- EIMindA
- Cheryl T. Herman Foundation
- Hoffman-La Roche
- Janssen
- Naurex
- Otsuka
- NIH
- Shire
- Takeda
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-Asberg Depression Rating Scale (MADRS) score at any post-baseline 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.
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