Effects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study

Rush, A. John; Sackeïm, Harold A.; Marangell, Lauren B.; George, Mark S.; Brannan, Stephen K.; Davis, Sonia M.; Lavori, Phil; Howland, Robert H; Kling, Mitchel A.; Rittberg, Barry R.; Carpenter, Linda L.; Ninan, Philip T.; Moreno, Francisco; Thomas, Sonia; Conway, Charles R.; Burke, Michael J.; Barry, John J.

doi:10.1016/j.biopsych.2005.05.024

Cited by 347 publications

(228 citation statements)

References 33 publications

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“…The first (Study 1) (n=233) was generated from a 12-month uncontrolled, long-term study of adult outpatients (18-75 years old) with highly treatment-resistant, nonpsychotic major depressive episodes (MDEs) who participated in a study of adjunctive vagus nerve stimulation added onto ongoing diverse medication regimens (Rush et al, 2005b). Diagnoses were rendered with the Structured Clinical Interview for DSM-IV (SCID) (First et al, 1994).…”

Section: Methodsmentioning

confidence: 99%

The Montgomery Äsberg and the Hamilton ratings of depression: A comparison of measures

Carmody

Rush

Bernstein

et al. 2006

European Neuropsychopharmacology

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The 17-item Hamilton Rating Scale for Depression (HRSD 17 ) and the Montgomery Äsberg Depression Rating Scale (MADRS) are two widely used clinicianrated symptom scales. A 6-item version of the HRSD (HRSD 6 ) was created by Bech to address the psychometric limitations of the HRSD 17 . The psychometric properties of these measures were compared using classical test theory (CTT) and item response theory (IRT) methods. IRT methods were used to equate total scores on any two scales. Data from two distinctly different outpatient studies of nonpsychotic major depression: a 12-month study of highly treatment-resistant patients (n=233) and an 8-week acute phase drug treatment trial (n=985) were used for robustness of results.MADRS and HRSD 6 items generally contributed more to the measurement of depression than HRSD 17 items as shown by higher item-total correlations and higher IRT slope parameters. The MADRS and HRSD 6 were unifactorial while the HRSD 17 contained 2 factors. The MADRS showed about twice the precision in estimating depression as either the HRSD 17 or HRSD 6 for average severity of depression. An HRSD 17 of 7 corresponded to an 8 or 9 on the MADRS and 4 on the HRSD 6 .The MADRS would be superior to the HRSD 17 in the conduct of clinical trials.

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Section: Methodsmentioning

confidence: 99%

The Montgomery Äsberg and the Hamilton ratings of depression: A comparison of measures

Carmody

Rush

Bernstein

et al. 2006

European Neuropsychopharmacology

Self Cite

200

132

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“…125 Evidence exists for modest efficacy at long-term (12 months) follow-up. 126,127 In recent years, chronic deep brain stimulation (DBS) in pathologically overactive neural circuits has been found to produce significant therapeutic benefits in those who suffer from Parkinson's disease. 128,129 In a preliminary and uncontrolled yet intriguing experiment, Mayberg et al 130 applied high-frequency DBS to the subgenual cingulate (BA25) of six subjects with severely treatment-refractory depression.…”

Section: Presumptive Mood Disorder Circuitsmentioning

confidence: 99%

Neural circuitry and neuroplasticity in mood disorders: Insights for novel therapeutic targets

Carlson¹,

Singh²,

Zarate³

et al. 2006

NeuroRX

136

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Summary:Major depressive disorder and bipolar disorder are severe mood disorders that affect the lives and functioning of millions each year. The majority of previous neurobiological research and standard pharmacotherapy regimens have approached these illnesses as purely neurochemical disorders, with particular focus on the monoaminergic neurotransmitter systems. Not altogether surprisingly, these treatments are inadequate for many individuals afflicted with these devastating illnesses. Recent advances in functional brain imaging have identified critical neural circuits involving the amygdala and other limbic structures, prefrontal cortical regions, thalamus, and basal ganglia that modulate emotional behavior and are disturbed in primary and secondary mood disorders. Growing evidence suggests that mechanisms of neural plasticity and cellular resilience, including impairments of neurotrophic signaling cascades as well as altered glutamatergic and glucocorticoid signaling, underlie the dysregulation in these circuits. The increasing ability to monitor and modulate activity in these circuits is beginning to yield greater insight into the neurobiological basis of mood disorders. Modulation of dysregulated activity in these affective circuits via pharmacological agents that enhance neuronal resilience and plasticity, and possibly via emerging nonpharmacologic, circuitry-based modalities (for example, deep brain stimulation, magnetic stimulation, or vagus nerve stimulation) offers promising targets for novel experimental therapeutics in the treatment of mood disorders.

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“…Table 2 summarizes the rates of AEs during the first year of VNS and displays them in comparison to published safety data from the D02 pivotal studies on VNS in depression (Rush et al 2005b). The most common side-effects in the acute study period were voice alteration (63 %), cough (26 %), pain (20 %) and dyspnoea (10 %).…”

Section: Adverse Events (Aes)mentioning

confidence: 99%

Vagus nerve stimulation for depression: efficacy and safety in a European study

et al. 2008

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Background. Vagus nerve stimulation (VNS) therapy is associated with a decrease in seizure frequency in partial-onset seizure patients. Initial trials suggest that it may be an effective treatment, with few side-effects, for intractable depression.Method. An open, uncontrolled European multi-centre study (D03) of VNS therapy was conducted, in addition to stable pharmacotherapy, in 74 patients with treatment-resistant depression (TRD). Treatment remained unchanged for the first 3 months ; in the subsequent 9 months, medications and VNS dosing parameters were altered as indicated clinically.Results. The baseline 28-item Hamilton Depression Rating Scale (HAMD-28) score averaged 34. After 3 months of VNS, response rates (o50 % reduction in baseline scores) reached 37 % and remission rates (HAMD-28 score <10) 17 %. Response rates increased to 53 % after 1 year of VNS, and remission rates reached 33 %. Response was defined as sustained if no relapse occurred during the first year of VNS after response onset ; 44 % of patients met these criteria. Median time to response was 9 months. Most frequent side-effects were voice alteration (63 % at 3 months of stimulation) and coughing (23 %).Conclusions. VNS therapy was effective in reducing severity of depression ; efficacy increased over time. Efficacy ratings were in the same range as those previously reported from a USA study using a similar protocol ; at 12 months, reduction of symptom severity was significantly higher in the European sample. This might be explained by a small but significant difference in the baseline HAMD-28 score and the lower number of treatments in the current episode in the European study.

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Effects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study

Cited by 347 publications

References 33 publications

The Montgomery Äsberg and the Hamilton ratings of depression: A comparison of measures

The Montgomery Äsberg and the Hamilton ratings of depression: A comparison of measures

Neural circuitry and neuroplasticity in mood disorders: Insights for novel therapeutic targets

Vagus nerve stimulation for depression: efficacy and safety in a European study

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