The American Psychiatric Association is pleased that patients will continue to have access to life-saving Electroconvulsive Therapy (ECT) following an FDA advisory panel’s two-day discussion about a possible reclassification of ECT devices.
“We’re optimistic that this life-saving procedure will continue to be available as a treatment option for patients with debilitating illnesses,” said APA President Carol Bernstein, M.D. “ECT is appropriate for a small percentage of patients, generally those with severe mental illnesses that have not responded to other treatments. When used properly, under the appropriate guidelines and by a well-trained psychiatrist, ECT is extremely safe and effective.”
The panel was asked to advise the FDA whether to reclassify ECT devices from Class III to the less restrictive Class II for medical devices. Under Class III, makers of the devices would be required to go through the extensive premarket approval process.
Sarah H. Lisanby, M.D., Chair of the APA Task Force to Revise the Practice of Electroconvulsive Therapy, said the panel hearing discussions highlighted the high prevalence of Major Depressive Disorder in the country and the suffering that this condition can cause, including the risk of suicide.
“There was a general consensus that ECT is effective for severe major depression when other treatments fail, which is consistent with recently published randomized large-scale NIMH-sponsored studies,” Dr. Lisanby said. “The continued availability for this life-saving treatment is of great importance to the patients who are suffering from severe depression that has not responded to other treatments.
“There was an acknowledgement that there are difficulties in performing controlled trials in acute and life-threatening conditions, such as catatonia. I am pleased that the FDA has undertaken a process to evaluate the evidence, and has sought the input of experts and consumer representatives on an issue of such high public health importance.”
Bernstein said the use of ECT should be a decision between the fully informed patient and the physician.
“As with any medical procedure, the risks and benefits for the patient should be carefully weighed.”
Source: American Psychiatric Association