The RAFT ECT Study
RAFT-ECT
The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
3 other identifiers
interventional
156
2 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedStudy Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2026
CompletedMarch 13, 2026
March 1, 2026
2.4 years
May 5, 2022
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary Outcomes (13)
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
From end of acute ECT treatment up to 24-week follow-up
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
From Baseline to end of randomized acute treatment (typically 4 weeks)
Clinical Global Impression-Severity (CGI-S)
From baseline to end of randomized acute treatment (typically 4 weeks)
Clinical Global Impression-Improvement (CGI-I)
Through the randomized acute ECT treatment period (typically 4 weeks)
Suicidality score
From baseline to end of randomized acute treatment (typically 4 weeks)
- +8 more secondary outcomes
Study Arms (2)
Frontoparietal ECT Group
EXPERIMENTALParticipants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes.
Temporoparietal ECT Group
ACTIVE COMPARATORParticipants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- DSM-5 diagnosis\* of major depressive episode (unipolar or bipolar)
- 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)
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institutelead
- National Health and Medical Research Council, Australiacollaborator
- Ramsay Clinic Albert Road, Australiacollaborator
- Ramsay Clinic Lakeside, Australiacollaborator
- Ramsay Clinic Northside, Australiacollaborator
- Gold Coast Hospital and Health Servicecollaborator
- Augusta Universitycollaborator
- Medical University of South Carolinacollaborator
- The University of New South Walescollaborator
- Emory Universitycollaborator
Study Sites (7)
Emory University
Atlanta, Georgia, 30322, United States
Medical College of Georgia, Augusta University
Augusta, Georgia, 30912, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Ramsay Clinic Northside
Sydney, New South Wales, 2065, Australia
Ramsay Clinic Lakeside
Warners Bay, New South Wales, 2282, Australia
Gold Coast University Hospital (GCUH)
Gold Coast, Queensland, 4215, Australia
Ramsay Clinic Albert Road
Melbourne, Victoria, 3004, Australia
Related Publications (1)
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.
PMID: 38968425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colleen Loo
University of New South Wales
- STUDY DIRECTOR
Anthony Rodgers
The George Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessors completing assessments of mood (primary outcome) will be blinded to the participant's treatment allocation until the database is locked and the primary analysis completed. Hospital ward personnel, if not involved in the delivery of ECT, will also be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2022
First Posted
June 2, 2022
Study Start
March 22, 2023
Primary Completion
August 19, 2025
Study Completion
February 13, 2026
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
De-identified individual participant data will be shared upon request to the data custodian, subject to approval from the Trial Steering Committee and signing of data transfer agreements.