Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2023-03-22
2026-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Frontoparietal ECT Group
Participants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes.
Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy
UBRUL-FP involves ultrabrief right unilateral ECT delivered using a novel frontoparietal montage, where the anterior electrode is shifted frontally to a position above the midpoint of the right eye to avoid temporal lobe stimulation (and reduce memory side effects). UBRUL-FP will be delivered using standard ECT devices.
Temporoparietal ECT Group
Participants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes.
Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy
UBRUL-TP is the standard form of ultrabrief right unilateral ECT, using the conventional temporoparietal (d'Elia) electrode placement, where the anterior electrode is placed over the right temporal lobe. UBRUL-TP will be delivered using standard ECT devices.
Interventions
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Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy
UBRUL-FP involves ultrabrief right unilateral ECT delivered using a novel frontoparietal montage, where the anterior electrode is shifted frontally to a position above the midpoint of the right eye to avoid temporal lobe stimulation (and reduce memory side effects). UBRUL-FP will be delivered using standard ECT devices.
Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy
UBRUL-TP is the standard form of ultrabrief right unilateral ECT, using the conventional temporoparietal (d'Elia) electrode placement, where the anterior electrode is placed over the right temporal lobe. UBRUL-TP will be delivered using standard ECT devices.
Eligibility Criteria
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Inclusion Criteria
* HRSD-17 score ≥ 17 at Screening
* At least 18 years old
* Able to tolerate washout of prohibited medications and restriction on benzodiazepine dosage, as determined by patient's own treating psychiatrist.
* ECT indicated for treatment of depression, as determined by own treating referring psychiatrist and confirmed by research evaluations (e.g., diagnosis of depression)
* Willing and able to participate in research and comply with study requirements
* Sufficient proficiency in spoken English to ensure validity of neuropsychological testing (e.g., worked or studied in an English-speaking context or equivalent)
Exclusion Criteria
* 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
* 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
* DSM-5 psychiatric diagnoses will be assessed and confirmed using the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) Version 7.0.2 for DSM-5, administered by research team members.
18 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Ramsay Clinic Albert Road, Australia
UNKNOWN
Ramsay Clinic Lakeside, Australia
UNKNOWN
Ramsay Clinic Northside, Australia
UNKNOWN
Gold Coast Hospital and Health Service
OTHER_GOV
Augusta University
OTHER
Medical University of South Carolina
OTHER
The University of New South Wales
OTHER
Emory University
OTHER
The George Institute
OTHER
Responsible Party
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Principal Investigators
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Colleen Loo
Role: PRINCIPAL_INVESTIGATOR
University of New South Wales
Anthony Rodgers
Role: STUDY_DIRECTOR
The George Institute
Locations
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Emory University
Atlanta, Georgia, United States
Medical College of Georgia, Augusta University
Augusta, Georgia, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Ramsay Clinic Northside
Sydney, New South Wales, Australia
Ramsay Clinic Lakeside
Warners Bay, New South Wales, Australia
Gold Coast University Hospital (GCUH)
Gold Coast, Queensland, Australia
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Loo C, Barreiros AR, Martin D, Dong V, George MS, McCall WV, Sarma S, Hopwood M, Weiss A, Bull M, Tuneu CM, Alonzo A, Hadzi-Pavlovic D, Rodgers A, Sahlem GL, Harvey AJ, Haldane K, Brettell L, Fitzgerald PB, Dokos S, Sackeim H. A Randomized Controlled Trial of Ultrabrief Right Unilateral ECT With Frontoparietal Versus Temporoparietal Electrode Placement for Severe Depression-The RAFT ECT Trial. J ECT. 2024 Dec 1;40(4):229-231. doi: 10.1097/YCT.0000000000001018. Epub 2024 Jul 5. No abstract available.
Other Identifiers
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APP1159769
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RG180233
Identifier Type: OTHER
Identifier Source: secondary_id
X22-0018
Identifier Type: -
Identifier Source: org_study_id
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