Researchers in Ireland and England assessed the short- and long-term effectiveness and cognitive side effects of high-dose unilateral ECT compared with bi-temporal ECT for severe depression in routine practice over six months. A total of 138 participants were randomly assigned to bi-temporal or high-dose unilateral ECT. “Seizure threshold”—the minimum charge required to induce the generalized seizure needed for therapeutic effect—was established by dose titration at the first session, and subsequent treatments were 1.5 times this threshold for bi-temporal ECT and six times this threshold for unilateral ECT.
The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HAM-D) score after the ECT course. A pre-specified range of a four-point difference was established as “non-inferior.” Secondary outcomes included response and remission rates, relapse status after six months, and cognition.
The researchers found that high-dose unilateral ECT was not inferior to bi-temporal ECT on HAM-D scores, with a mean difference of 1.08 points in favor of unilateral ECT (within the range of “non-inferiority”). There were no significant differences for response and remission or six-month relapse status. Recovery of orientation was quicker following unilateral ECT, and bi-temporal ECT was associated with a lower percent recall of autobiographical information.
“Our findings justify considering high-dose unilateral ECT as the preferred ECT option for treating depression and may help improve acceptability and availability of this effective treatment,” wrote Maria Semkovska, Ph.D., of the Department of Psychiatry at Trinity College Dublin and colleagues.
In Related News on ECT--APA Urges Your Involvement
The Food and Drug Administration (FDA) is proposing to reclassify ECT from a Class III (high risk) medical device to Class II (low risk), a change APA supports. APA urges psychiatrists to contribute their comments to the FDA in favor of the reclassification. A template letter has been prepared that provides talking points. The FDA must receive comments by March 28.
“[I]t is so important for psychiatrists to take the lead in expressing their views in regard to the role that ECT plays in clinical practice and in the treatment of major depressive disorder,” wrote APA CEO and Medical Director Saul Levin, M.D., M.P.A., and APA President Renée Binder, M.D., in a blog post. “For appropriate patients, ECT has been a lifesaver. It has given them an opportunity for a normal, functional life.”
For information about previous efforts to reclassify ECT, see the Psychiatric News article “FDA Advisory Panel Favors ECT in High-Risk Category.”