Emergence of mania in two middle‐aged patients with a history of unipolar treatment‐refractory depression receiving vagus nerve stimulation

Salloum, Naji C.; Walker, Marie C.; Gangwani, Sunil; Conway, Charles R.

doi:10.1111/bdi.12463

Cited by 8 publications

(6 citation statements)

References 32 publications

(74 reference statements)

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“…Intense light therapy and sleep deprivation are plausible candidates that require adequate testing in BD (Tseng et al 2016;Suzuki et al 2018). Vagal nerve stimulation (VNS) is FDA-approved for treatment-resistant depression, with evidence of efficacy in depression of BD and MDD (Cimpianu et al 2017;Conway et al 2018), though with some risk of inducing mania (Salloum et al 2017). Repeated transcranial magnetic stimulation (rTMS) and various forms of electrical stimulation of brain from the surface or through stereotaxically placed deep-brain electrodes remain experimental for bipolar depression (Nierenberg et al 2008;Vázquez et al 2017a;Widge et al 2018;Filkowski and Sheth 2019).…”

Section: Other Treatmentsmentioning

confidence: 99%

Bipolar depression: a major unsolved challenge

Baldessarini

Vázquez

Tondo

2020

Int J Bipolar Disord

155

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Depression in bipolar disorder (BD) patients presents major clinical challenges. As the predominant psychopathology even in treated BD, depression is associated not only with excess morbidity, but also mortality from co-occurring general-medical disorders and high suicide risk. In BD, risks for medical disorders including diabetes or metabolic syndrome, and cardiovascular disorders, and associated mortality rates are several-times above those for the general population or with other psychiatric disorders. The SMR for suicide with BD reaches 20-times above general-population rates, and exceeds rates with other major psychiatric disorders. In BD, suicide is strongly associated with mixed (agitated-dysphoric) and depressive phases, time depressed, and hospitalization. Lithium may reduce suicide risk in BD; clozapine and ketamine require further testing. Treatment of bipolar depression is far less well investigated than unipolar depression, particularly for long-term prophylaxis. Short-term efficacy of antidepressants for bipolar depression remains controversial and they risk clinical worsening, especially in mixed states and with rapid-cycling. Evidence of efficacy of lithium and anticonvulsants for bipolar depression is very limited; lamotrigine has long-term benefit, but valproate and carbamazepine are inadequately tested and carry high teratogenic risks. Evidence is emerging of short-term efficacy of several modern antipsychotics (including cariprazine, lurasidone, olanzapine-fluoxetine, and quetiapine) for bipolar depression, including with mixed features, though they risk adverse metabolic and neurological effects.

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Section: Other Treatmentsmentioning

confidence: 99%

Bipolar depression: a major unsolved challenge

Baldessarini

Vázquez

Tondo

2020

Int J Bipolar Disord

155

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“…Since the US FDA approval, several large clinical trials of VNS in TRD have been conducted. These trials clarified clinical response patterns including: 1) higher delivered charge results in more sustained antidepressant response [1]; 2) nonetheless, some TRD patients respond at very low electrical parameters [1]; 3) patients who fail ECT may respond to VNS [2]; 4) many TRD patients exhibit a markedly delayed response (9-12 months or longer) to VNS [2,42]; 5) clinically meaningful quality-of-life improvements occur in TRD patients, even when response is below the classic definition of antidepressant response, 50% reduction from baseline scores [8]; 6) many TRD patients have sustained benefit that may last for 10 or more years [48]. Furthermore, mechanism of action studies have contributed to our understanding of VNS in TRD.…”

Section: Trial Design and Purposementioning

confidence: 99%

“…Other criteria to ensure patient safety include the requirement that patients with bipolar disorder concomitantly be treated with a mood stabilizer, as VNS, like most antidepressants, can be associated with the emergence of hypomania or mania in bipolar patients [19,26,48].…”

Section: Participantsmentioning

confidence: 99%

A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment

Conway

Olin

Aaronson

et al. 2020

Contemporary Clinical Trials

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Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a "coverage with evidence" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.

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“…Schon in den ersten Zulassungsstudien wurde von Einzelfällen von Patienten mit Diagnose einer unipolaren Depression berichtet, bei denen die VNS-Therapie eine manische Episode induzierte. Rush [47]. Die manischen Symptome konnten erfolgreich mit EKT und Lithium behandelt werden, sodass beide Patienten eine Langzeittherapie (> 5 Jahre) mit VNS fortführtenohne Wiederauftreten von manischen Episoden.…”

Section: Vns Und Manieunclassified

Vagusnervstimulation bei affektiven Störungen

Dibué-Adjei

Kamp

Vogelsang

et al. 2020

Fortschr Neurol Psychiatr

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ZusammenfassungVagusnervstimulation (VNS) ist ein minimalinvasives Neurostimulationsverfahren und wurde 1994 in Europa für die Behandlung von Kindern und Erwachsenen mit medikamentenresistenten Epilepsien zugelassen. Die Beobachtung, dass sich Depressionen, die häufigste Komorbidität der Epilepsie, signifikant unter VNS verbesserten, initiierte Studien der VNS bei Patienten mit therapieresistenten Depressionen (TRD), die 2001 zu der europäischen Zulassung der VNS für TRD führten. Heutzutage ist in Deutschland der Einsatz der VNS für TRD-Patienten auf wenige hochspezialisierte (oft universitäre) Zentren limitiert und das Verfahren in der psychiatrischen Praxis weitestgehend unbekannt. In dieser systematischen Übersicht identifizieren und diskutieren wir deshalb die aktuellsten Studien zu VNS bei TRD sowie Empfehlungen von Fachgesellschaften und diskutieren den Einsatz der VNS in der klinischen Praxis. In den letzten fünf Jahren wurden fünf Studien mit Evidenzgrad 2 und vier Studien mit Evidenzgrad 3 zu der Wirkung von VNS bei TRD-Patienten publiziert. Kurzfristige Wirksamkeit der VNS konnte in klinischen Studien nicht gezeigt werden. Mehrere Studien demonstrieren die Langzeitwirksamkeit der VNS. Die kürzlich publizierte größte Untersuchung der Thematik bestätigt signifikant bessere Behandlungsergebnisse bei Patienten, die eine Zusatztherapie mit VNS erhielten – im Vergleich zu Patienten, die nur Behandlung nach Goldstandard über fünf Jahre erhielten. Die langfristige Wirksamkeit der VNS bei TRD-Patienten ist mit Evidenz des Grades 2 belegt, jedoch ist es unklar, welche TRD-Patienten die höchste Wahrscheinlichkeit eines Ansprechens auf VNS haben, was die Patientenselektion in der Praxis erschweren kann. Zusätzlich wirkt sich möglicherweise die unklare und variable Definition der therapieresistenten Depression problematisch auf den rechtzeitigen Einsatz von Neurostimulationsverfahren aus.

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Emergence of mania in two middle‐aged patients with a history of unipolar treatment‐refractory depression receiving vagus nerve stimulation

Cited by 8 publications

References 32 publications

Bipolar depression: a major unsolved challenge

Bipolar depression: a major unsolved challenge

A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment

Vagusnervstimulation bei affektiven Störungen

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