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About
Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Of these, retrograde memory loss is most concerning, and can be long-term. The introduction of ultrabrief right unilateral (UBRUL) ECT into clinical practice has been an important step in reducing the risk of memory impairment, but significant deficits still occur.
A new form of UBRUL ECT which utilises a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal UBRUL has good efficacy and less cognitive side effects than UBRUL given using the conventional Temporoparietal electrode placement. Designed as a pivotal trial, this protocol will be the first RCT comparing these two forms of ECT, producing the rigorous efficacy and safety data required to change clinical practice/policy.
This is a multicentre, parallel group RCT with 1:1 allocation ratio between Frontoparietal (intervention) and Temporoparietal (comparator) forms of UBRUL ECT. Participation will involve receiving randomised acute ECT under blinded conditions during the randomised acute treatment period (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomised acute ECT treatments, though the number of treatments (and hence the length of the randomised acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgement.
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Inclusion criteria
Exclusion criteria
History of schizophrenia, schizoaffective disorder, other [non-mood disorder] psychosis, or rapid cycling bipolar disorder (DSM-5 diagnoses*)
Current manic episode, hypomanic episode, or major depressive episode with mixed features (DSM-5 diagnoses*)
Alcohol or substance use disorder (other than caffeine or nicotine) present in the past month, or is likely to be present during the 24-week study period as determined by study physician evaluation
Diagnosis of amnestic disorder, dementia, delirium, or epilepsy, as determined by study physician evaluation and medical history
Central nervous system disease or brain injury that has resulted in significant cognitive impact, as determined by study physician evaluation and medical history
Serious or unstable medical condition, as determined by study physician evaluation and medical history
If female of childbearing potential: a) pregnancy as determined by pregnancy urine screen, and/or b) current breastfeeding
Completed an acute course of ECT during the past 2 months, as determined by treatment history
Received any ECT during the past 2 weeks
Failed an adequate course of ECT (i.e., 8 ECT treatments ) in the current depressive episode
Patients who are prisoners, and those who lack capacity to make medical decisions (as judged by their own treating psychiatrist)
Currently enrolled in another interventional clinical trial
Currently using another investigational device or product
Primary purpose
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154 participants in 2 patient groups
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Central trial contact
Rita Barreiros; Louise Brettell
Data sourced from clinicaltrials.gov
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