Hostname: page-component-78c5997874-fbnjt Total loading time: 0 Render date: 2024-11-19T08:31:13.496Z Has data issue: false hasContentIssue false

FDA Considers Classification of ECT

Published online by Cambridge University Press:  07 November 2014

Extract

With the increasing number of new brain stimulation techniques now available and on the horizon, does electroconvulsive therapy (ECT) still have a role? As clinicians and researchers we say most definitely “yes”. ECT is the most effective and rapidly acting treatment for severe forms of depression and other disorders. Transcranial magnetic stimulation has shown promise but mainly for less severely ill and less treatment resistant patients. Deep brain stimulation (DBS) has shown promise for the more resistant cases but its invasiveness limits its use. Results from only ∼50 patients treated worldwide are available and at present it is not approved by the United States Food and Drug Administration for depression. Vagus nerve stimulation, less invasive than DBS but still a surgical procedure, is presently FDA approved for acute treatment resistant depression but published efficacy rates fall short of those seen with ECT. Therefore, there continues to be an important role for ECT in the treatment of severe psychiatric disorders. But will ECT always be there when our patients need it? Somewhat unexpected recent developments at the FDA may impact the future availability of ECT to severely depressed patients. Here we provide background on the classification of ECT devices, the FDA reclassification process, and the process for providing FDA input in these critical deliberations.

Type
Brain Stimulation
Copyright
Copyright © Cambridge University Press 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.O'Reardon, JP, Solvason, HB, Janicak, PG, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007;62:12081216.CrossRefGoogle ScholarPubMed
2.Lisanby, SH, Husain, MM, Rosenquist, PB, et al. Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial.Neuropsychopharmacology. 2009:34:522534.CrossRefGoogle Scholar
3.Lozano, AM, Mayberg, HS, Giacobbe, P, Hamani, C, Craddock, RC, Kennedy, SH. Subcallosal cingulate gyrus deep brain stimulation for treatment-resistant depression. Biol Psychiatry. 2008;64:461467.CrossRefGoogle ScholarPubMed
4.Malone, DA Jr., Dougherty, DD, Rezai, AR, et al. Deep brain stimulation of the ventral capsule/ventral striatum for treatment-resistant depression. Biol Psychiatry. 2009;65:267275.CrossRefGoogle ScholarPubMed
5.Rush, AJ, Sackeim, HA, Marangell, LB, et al. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study. Biol Psychiatry. 2005;58:355363.CrossRefGoogle ScholarPubMed
6.Dukakis, K, Tye, L. Shock: the Healing Power of Electroconvulsive Therapy. New York, NY: Avery; 2006.Google Scholar
7.American Psychiatric Association. Task Force on Electroconvulsive Therapy: The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging. Washington, DC: American Psychiatric Association; 2001.Google Scholar