{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T14:06:29Z","timestamp":1791986789180,"version":"4.4.0"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,5,2]],"date-time":"2020-05-02T00:00:00Z","timestamp":1588377600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,5,2]],"date-time":"2020-05-02T00:00:00Z","timestamp":1588377600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100013410","name":"LivaNova, PLC","doi-asserted-by":"crossref","award":["VNS TRD Registry"],"award-info":[{"award-number":["VNS TRD Registry"]}],"id":[{"id":"10.13039\/100013410","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Bipolar Disord"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>To compare illness characteristics, treatment history, response and durability, and suicidality scores over a 5-year period in patients with treatment-resistant bipolar depression participating in a prospective, multicenter, open-label registry and receiving Vagus Nerve Stimulation Therapy (VNS Therapy) plus treatment-as-usual (VNS\u2009+\u2009TAU) or TAU alone.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Response was defined as\u2009\u2265\u200950% decrease from baseline Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) total score at 3, 6, 9, or 12\u00a0months post-baseline. Response was retained while MADRS score remained\u2009\u2265\u200940% lower than baseline. Time-to-events was estimated using Kaplan\u2013Meier (KM) analysis and compared using log-rank test. Suicidality was assessed using the MADRS Item\u00a010 score.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>At baseline (entry into registry), the VNS\u2009+\u2009TAU group (N\u2009=\u200997) had more episodes of depression, psychiatric hospitalizations, lifetime suicide attempts and higher suicidality score, more severe symptoms (based on MADRS and other scales), and higher rate of prior electroconvulsive therapy than TAU group (N\u2009=\u200959). Lifetime use of medications was similar between the groups (a mean of 9) and was consistent with the severe treatment-resistant nature of their depression. Over 5\u00a0years, 63% (61\/97) in VNS\u2009+\u2009TAU had an initial response compared with 39% (23\/59) in TAU. The time-to-initial response was significantly quicker for VNS\u2009+\u2009TAU than for TAU (p\u2009&lt;\u20090.03). Among responders in the first year after implant, the KM estimate of the median time-to-relapse from initial response was 15.2 vs 7.6\u00a0months for VNS\u2009+\u2009TAU compared with TAU (difference was not statistically significant). The mean reduction in suicidality score across the study visits was significantly greater in the VNS\u2009+\u2009TAU than in the TAU group (p\u2009&lt;\u20090.001).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The patients who received VNS\u2009+\u2009TAU included in this analysis had severe bipolar depression that had proved extremely difficult to treat. The TAU comparator group were similar though had slightly less severe illnesses on some measures and had less history of suicide attempts. Treatment with VNS\u2009+\u2009TAU was associated with a higher likelihood of attaining a response compared to TAU alone. VNS\u2009+\u2009TAU was also associated with a significantly greater mean reduction in suicidality.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Limitations<\/jats:title>\n                <jats:p>In this registry study, participants were not randomized to the study treatment group, VNS Therapy stimulation parameters were not controlled, and there was a high attrition rate over 5\u00a0years.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> ClinicalTrials.gov NCT00320372. Registered 3 May 2006, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00320372\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00320372<\/jats:ext-link> (retrospectively registered)<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40345-020-0178-4","type":"journal-article","created":{"date-parts":[[2020,5,1]],"date-time":"2020-05-01T23:04:54Z","timestamp":1588374294000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["The effects of vagus nerve stimulation on the course and outcomes of patients with bipolar disorder in a treatment-resistant depressive episode: a 5-year prospective registry"],"prefix":"10.1186","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct00320372","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9966-1834","authenticated-orcid":false,"given":"R. 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De-identified participant\u2019s data for the VNS TRD Registry will not be shared. Please contact the corresponding author for data requests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"Study procedures were reviewed and approved by an institutional review board for each participating site. All enrolled participants provided written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Dr. McAllister-Williams has received speaker honorarium fees, fees for consultancy, and\/or support for research from AstraZeneca, Bristol Myers-Squibb, Compass Inc., Cyberonics, Eli Lilly, Ferrer, GlaxoSmithKline, Janssen, Janssen-Cilag, LivaNova PLC, Lundbeck, MagStim, Merck Sharp & Dohme, myTomorrows, Otsuka, Pfizer, Pulse, Roche, Servier, SPIMACO, Sunovian, Syntropharma, Wyeth, American Center for Psychiatry & Neurology in the United Arab Emirates, British Association for Psychopharmacology, European College of Neuropsychopharmacology, International Society for Affective Disorders, OCM Comunicaziona s.n.c., Qatar International Mental Health Conference, UK Medical Research Council, and Wiley; grant support from National Institute for Health Research Efficacy and Mechanism Evaluation Panel and Health Technology Assessment Panel; and non-financial support from COMPASS Pathways. Dr. Sousa has no competing interests to disclose. Dr. Kumar is a former employee of LivaNova USA PLC. Dr. Greco is an employee of LivaNova PLC. Dr Bunker is a former employee and a current consultant of LivaNova USA PLC. Dr. Aaronson has received consulting fees from Genomind, LivaNova PLC, Alkermes, and Neuronetics; research support from Neuronetics; and speaker honorarium fees from Neurocrine, Otsuka, and Sunovion. Dr. Conway has received research support from Bristol-Myers Squibb, the Stanley Medical Research Institute, the National Institute of Mental Health, NeoSync, Cyberonics, Taylor Family Institute for Innovative Psychiatric Research, The American Foundation for Suicide Prevention, Assurex Health Inc., August Busch IV Foundation, and Barnes-Jewish Hospital Foundation; and he is currently serving as a research consultant to LivaNova PLC. Dr. Rush has received consulting fees from Akili Interactive Labs, Inc., Brain Resource, Compass Inc., Curbstone Consultant LLC., Emmes Corp., Holmusk, Inc., LivaNova PLC, Johnson and Johnson (Janssen), and MindLinc; speaking fees from LivaNova PLC; and royalties from Guilford Press and the University of Texas Southwestern Medical Center Dallas, TX (for the Inventory of Depressive Symptoms and its derivatives); and he is also named co-inventor on 2\u00a0patents: US Patent No.\u00a07,795,033: Methods to Predict the Outcome of Treatment with Antidepressant Medication (Inventors: McMahon FJ, Laje G, Manji H, Rush AJ, Paddock S, Wilson AS) and US Patent No.\u00a07,906,283: Methods to Identify Patients at Risk of Developing Adverse Events During Treatment with Antidepressant Medication (Inventors: McMahon FJ, Laje G, Manji H, Rush AJ, Paddock S).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"13"}}