2023-06-06 04:35:48
Why is this important?
With 80 years of hindsight, ECT (formerly shock therapy) appears to be one of the fastest and most effective treatments for resistant major depression. The optimization of anesthesia and stimulation techniques now makes it possible to practice it on an outpatient basis, but the technique remains underused because of the fears it arouses concerning, in particular, possible memory loss. Ketamine is an NMDA receptor antagonist which has marketing authorization in France for general anaesthesia. A rapid antidepressant effect has been observed for regarding twenty years in resistant major depression without psychotic events, with sub-anaesthetic doses (0.5 mg/kg of body weight). Because it does not require anesthesia and does not cause memory loss, it is very popular with patients and its use is increasingly frequent in the treatment of resistant depression. It remained to demonstrate its non-inferiority to ECT, which an American team from the Brigham Hospital and some Harvard Medical School (Boston).
Methodology
This prospective non-inferiority trial was performed in an open-label setting in patients referred to 5 US clinics or hospitals to receive ECT to treat resistant depression without psychosis. Subjects were randomized to receive ketamine twice a week by IV route at a subanesthetic dose (0.5 mg/kg body weight over 40 minutes), or electroconvulsive therapy (ECT) 3 times a week for 3 weeks.
The primary endpoint was response to treatment. Patients were considered responders if they had a reduction of at least 50% in their initial score at Quick Inventory of Depressive Symptomatology-Self-Report to 16 items (QIDS-SR-16, score from 0 to 27, 27 being attributed to the most severe cases). Secondary endpoints included patient-reported scores on memory and quality of life tests.
Principle results
The study thus randomized 403 patients, 200 in the ketamine group and 203 in the ECT group, and the treatment might be administered to 365 patients, 195 in the ketamine group and 170 in the ECT group. In this intention-to-treat population, the average age was 46 years, 51% of the participants were women and the vast majority (89%) were not hospitalized during randomisation.
After 3 weeks of treatment, 55.4% of patients were judged to be responders according to the QIDS-SR-16 score in the ketamine group and 41.2% in the ECT group, i.e. a significant difference of 14.2 points percentage (p<0.001) in favor of the non-inferiority of ketamine compared to ECT. Remission according to this same score was obtained in 32% of patients in the Ketamine group and 20% of those in the ECT group.
Memory performance was lower in the ECT group compared to the ketamine group according to the score Global Self-Evaluation of Memory (GSE-My: 3.2 vs 4.2) and fewer patients complained of cognitive impairment in the ketamine group according to the Squire Memory Complaint Questionnaire (SMCQ). The memory recall delay was also greater in the ECT group according to the score Hopkins Verbal Learning Test-Revised (HVLT-R : -9,7 ±1,2 vs -0,9 ±1,1).
As for the improvement in the quality of life reported by the patients (16-items Quality-of-Life Scale), it was similar in the two groups, the number of treatment sessions being otherwise equivalent.
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