New Study Shows Significant Positive Impact of Vagus Nerve Stimulation Therapy for Patients with Treatment-Resistant Bipolar Depression
“Given the significant unmet need with regard to the management of bipolar depression patients, it is critical that alternative treatment options for patients with TRBD are explored,” said Dr.
Bipolar patients are symptomatic nearly half of the time and the majority of their symptoms are depression related, yet safe, effective, long-term treatment options are scarce.2 Similar to patients with difficult-to-treat depression (DTD), this TRBD subpopulation struggles to get well and stay well with 30% remaining depressed at 12 months despite initiation of antidepressant treatment.3 A significant fraction of the disease burden in bipolar disorder is suicide-related and it is estimated that between 25% and 60% of individuals with bipolar disorder will attempt suicide at least once in their lives and between 4% and 19% will complete suicide.4
“LivaNova is dedicated to helping patients who suffer from treatment-resistant bipolar depression,” said
The study was conducted with a patient population of 156 TRBD patients with 97 in the adjunctive VNS Therapy group and 59 in the TAU group. Before treatment, subjects in the adjunctive VNS Therapy group had, on average, suffered from 20.7 lifetime episodes of depression, had approximately three lifetime suicide events and had been treated with nine different therapies, including an antidepressant at some point. In comparison to the TAU group and prior to the study, patients in the adjunctive VNS Therapy group had experienced more episodes of depression, psychiatric hospitalizations, lifetime suicide attempts, along with a higher suicidality score and more severe symptoms based on MADRS and other scales at baseline.
The study concluded that VNS Therapy as an adjunctive treatment to TAU was more effective than TAU alone in reducing depressive symptoms and suicidal ideation. In addition, patients who received adjunctive VNS Therapy had a more rapid onset of response and more durable antidepressant effects. The study drew the conclusion that adjunctive VNS Therapy is an efficacious antidepressant treatment for patients with TRBD.
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Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding VNS Therapy and its use for difficult-to-treat depression. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended
References
1 |
McAllister-Williams, R.H., Sousa, S., Kumar, A. et al. 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. Int J Bipolar Disord 8, 13 (2020). https://doi.org/10.1186/s40345-020-0178-4. |
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2 |
Judd et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry, 2002; 2003. |
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3 |
Kupfer et al. Stabilization in the treatment of mania, depression and mixed states. Acta Neuropsychiatr, 2000. |
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4 |
Goodwin FK, Jamison KR. Manic-Depressive Illness. |
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