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ECTThe RAFT ECT Study

Sponsor:

The George Institute

Code:

NCT05402657

Conditions

Major Depressive Episode

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy

Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy

Study Details

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.

Conditions

Major Depressive Episode

Study ID

NCT05402657

Start date

Mar 22, 2023

Status verified date

Apr, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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)

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
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.

Study Design

Enrollment

154 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Frontoparietal ECT Group

Participants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes.

active comparator: Temporoparietal ECT Group

Participants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes.

Interventions

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.

Primary outcome measure

Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17 [ Time Frame: From baseline to end of randomized acute treatment (typically 4 weeks) ]

Central Contacts and Locations

Central contacts

Rita Barreiros

+61 2 9065 9107 raft-ect.study@unsw.edu.au

Louise Brettell

raft-ect.study@unsw.edu.au

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jonathan Kim

(404) 712-6939 jonathan.min-hyuk.kim@emory.edu

Principal Investigator:

Adriana Hermida

Medical College of Georgia, Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Laryssa McCloud

(706)721-7968 lmccloud@augusta.edu

Principal Investigator:

W. Vaughn McCall

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Morgan Dancy

843-876-5141 maddoxm@musc.edu

Principal Investigator:

Mark George

More Information

Sponsor

The George Institute

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Keywords

Severe depression
Depressive Disorder, Treatment-Resistant
Depressive Disorder, Major
Memory
Electroconvulsive therapy
Randomised clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by The George Institute on 2025-04-11.