After years of consideration, the Food and Drug Administration has determined that for carefully selected patients with profound depression, the benefits of electroconvulsive therapy, long demonized, outweigh the risks of possible memory loss caused by its use.
Citing evidence from 60 randomized trials of ECT, once known as electroshock therapy, the FDA acknowledged the risk but said that there is now enough evidence to ease access to the therapy for certain people.
The devices that are used to administer ECT are regulated by the agency as Class III. That is the highest-risk designation, and it makes the equipment subject to the highest level of regulatory control. The FDA is proposing to downgrade that assessment to Class II for those whose depression has not responded to other treatments or is so severe that they need the kind of rapid response that only ECT can provide.
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