Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial

@article{Rush2005VagusNS,
  title={Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial},
  author={A. Rush and L. Marangell and H. Sackeim and M. George and S. Brannan and S. Davis and R. Howland and M. Kling and B. Rittberg and W. Burke and M. Rapaport and J. Zajecka and A. Nierenberg and M. Husain and D. Ginsberg and R. Cooke},
  journal={Biological Psychiatry},
  year={2005},
  volume={58},
  pages={347-354}
}
BACKGROUND Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. METHODS This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with nonpsychotic major depressive disorder (n = 210) or nonpsychotic, depressed phase, bipolar disorder (n = 25). In the current… Expand

Paper Mentions

Observational Clinical Trial
This registry will collect information about patients with treatment-resistant depression (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is… Expand
ConditionsMajor Depressive Disorder
Interventional Clinical Trial
This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different… Expand
ConditionsDepression
InterventionDevice
Interventional Clinical Trial
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.  
ConditionsMajor Depressive Disorder
InterventionDevice
Vagus nerve stimulation for depression: efficacy and safety in a European study
TLDR
VNS therapy was effective in reducing severity of depression; efficacy increased over time; reduction of symptom severity was significantly higher in the European sample than previously reported. Expand
Vagus Nerve Stimulation Therapy Randomized to Different Amounts of Electrical Charge for Treatment-Resistant Depression: Acute and Chronic Effects
TLDR
TRD patients who received adjunctive VNS showed significant improvement at study endpoint compared with baseline, and the effect was durable over 1 year. Expand
Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study
TLDR
It is shown that long-term VNS may be effective in reducing severity of depression in a small but significant minority of patients, although two patients had stimulation terminated because of adverse effects and/or refusal to continue the study. Expand
Serial Vagus Nerve Stimulation Functional MRI in Treatment-Resistant Depression
TLDR
It is suggested that similar to other antidepressant treatments, BOLD deactivation in the ventro-medial prefrontal cortex correlates with the antidepressant response to VNS therapy. Expand
A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders
TLDR
These patients with treatment-resistant anxiety disorders generally tolerated VNS treatment, and there was evidence of acute and long-term improvement in some patients, suggesting that further double-blind studies assessing the VNS role in treating anxiety disorders, particularly OCD, may be warranted. Expand
Two-Year Outcome of Vagus Nerve Stimulation in Treatment-Resistant Depression
TLDR
The results of this 2-year open-label trial suggest a clinical response and a comparatively benign adverse effect profile among patients with treatment-resistant depression. Expand
Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial
TLDR
This double-blinded randomized clinical trial has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders. Expand
Double Blinded Randomized Trial of Subcutaneous Trigeminal Nerve Stimulation as Adjuvant Treatment for Major Unipolar Depressive Disorder.
TLDR
This study protocol is designed to define efficacy of a novel adjuvant therapy for TRD, and must strive to develop safe, reproducible, predictable, and well-tolerated neuromodulation approaches forTRD patients impaired to manage their lives and contribute with society. Expand
Vagus nerve stimulation for chronic major depressive disorder: 12-month outcomes in highly treatment-refractory patients.
TLDR
Response rates at 12 months for patients with chronic and highly-refractory major depression are broadly consistent with previously published results in more heterogeneous and less refractory clinical trial populations, and in highly treatment-resistant patients, the rate of response with VNS at 12 m is at least twice that anticipated with 'treatment-as-usual'. Expand
Vagus nerve stimulation for treatment-resistant depression: protocol for a pilot self-controlled trial
TLDR
The trial will provide objective data on the potential of the clinical implementation of VNS as a treatment for TRD in China and disseminate the results of the study through presentations at peer-reviewed publications. Expand
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References

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Vagus nerve stimulation (VNS) for major depressive episodes: one year outcomes
TLDR
Longer-term vagus nerve stimulation treatment was associated with sustained symptomatic benefit and sustained or enhanced functional status in this naturalistic follow-up study. Expand
Vagus Nerve Stimulation (VNS™) for Treatment-Resistant Depression: Efficacy, Side Effects, and Predictors of Outcome
TLDR
VNS appears to be most effective in patients with low to moderate, but not extreme, antidepressant resistance, and evidence concerning VNS' long-term therapeutic benefits and tolerability will be critical in determining its role in treatment-resistant depression. Expand
Vagus nerve stimulation (VNS) for treatment-resistant depressions: a multicenter study∗ ∗ See accompanying Editorial, in this issue.
TLDR
These open trial results suggest that VNS has antidepressant effects in treatment-resistant depressions. Expand
Vagus nerve stimulation is associated with mood improvements in epilepsy patients
TLDR
VNS is associated with mood improvements in patients with epilepsy, but to confirm VNS dose effects, studies with more statistical power are needed. Expand
The effects of vagus nerve stimulation on cognitive performance in patients with treatment-resistant depression.
TLDR
Vagus nerve stimulation in treatment-resistant depression may result in enhanced neurocognitive function, primarily among patients who show clinical improvement, and controlled investigation is needed to rule out the contribution of practice effects. Expand
Vagus nerve stimulation therapy for partial-onset seizures
TLDR
Vagus nerve stimulation is an effective and safe adjunctive treatment for patients with refractory partial-onset seizures and represents the advent of a new, nonpharmacologic treatment for epilepsy. Expand
A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation
TLDR
VNS treatment is associated with mood improvement as measured by multiple scales, but differences in mood scale scores over time between the VNS and a comparison group were not found, suggesting dissociation between seizure frequency reduction and mood change. Expand
A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures
TLDR
VNS may be an effective alternative treatment for patients who have failed antiepileptic drug therapy and are not optimal candidates for epilepsy surgery, and largely limited to a transient hoarseness occurring during the stimulation train. Expand
Effect of vagus nerve stimulation on cerebrospinal fluid monoamine metabolites, norepinephrine, and gamma-aminobutyric acid concentrations in depressed patients
TLDR
Several of the CSF neurochemical effects observed in this VNS study were similar to those described in the literature for antidepressants and electroconvulsive therapy, but the results do not suggest a putative antidepressant mechanism of action for VNS. Expand
Vagus Nerve Stimulation for Treatment of Partial Seizures: 1. A Controlled Study of Effect on Seizures
TLDR
The effectiveness of VNS as treatment for epilepsy patients with refractory partial seizures was confirmed and high VNS was more effective in reducing partial seizure frequency than was low VNS. Expand
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