1. 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
- Author
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R. Hamish McAllister-Williams, Soraia Sousa, Scott Aaronson, A. John Rush, Teresa Greco, Charles R. Conway, Mark Bunker, and Arun Kumar
- Subjects
medicine.medical_specialty ,Neurology ,Bipolar disorder ,medicine.medical_treatment ,Biophysics ,Neurosciences. Biological psychiatry. Neuropsychiatry ,Suicidality ,lcsh:RC321-571 ,Electroconvulsive therapy ,Rating scale ,Internal medicine ,medicine ,In patient ,lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry ,Treatment resistant ,Biological Psychiatry ,Depression (differential diagnoses) ,Depression ,business.industry ,Research ,General Neuroscience ,lcsh:QP351-495 ,Response ,medicine.disease ,Psychiatry and Mental health ,lcsh:Neurophysiology and neuropsychology ,Vagus Nerve Stimulation Therapy ,VNS TRD registry ,Neurology (clinical) ,Implant ,Treatment-resistant depression ,business ,Vagus nerve stimulation ,RC321-571 - Abstract
Background 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 + TAU) or TAU alone. Methods Response was defined as ≥ 50% decrease from baseline Montgomery–Åsberg Depression Rating Scale (MADRS) total score at 3, 6, 9, or 12 months post-baseline. Response was retained while MADRS score remained ≥ 40% lower than baseline. Time-to-events was estimated using Kaplan–Meier (KM) analysis and compared using log-rank test. Suicidality was assessed using the MADRS Item 10 score. Results At baseline (entry into registry), the VNS + TAU group (N = 97) 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 = 59). 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 years, 63% (61/97) in VNS + TAU had an initial response compared with 39% (23/59) in TAU. The time-to-initial response was significantly quicker for VNS + TAU than for TAU (p Conclusions The patients who received VNS + TAU 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 + TAU was associated with a higher likelihood of attaining a response compared to TAU alone. VNS + TAU was also associated with a significantly greater mean reduction in suicidality. Limitations 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 years. Trial registration ClinicalTrials.gov NCT00320372. Registered 3 May 2006, https://clinicaltrials.gov/ct2/show/NCT00320372 (retrospectively registered)
- Published
- 2021
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