The RAFT ECT Study

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Ramsay Clinic Albert Road, Australia

  collaborator UNKNOWN

• Ramsay Clinic Lakeside, Australia

  collaborator UNKNOWN

• Ramsay Clinic Northside, Australia

  collaborator UNKNOWN

• Gold Coast Hospital and Health Service

  collaborator OTHER_GOV

• Augusta University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• The University of New South Wales

  collaborator OTHER

• Emory University

  collaborator OTHER

• The George Institute

  lead OTHER

Principal Investigators

• Colleen Loo · University of New South Wales

• Anthony Rodgers · The George Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-22

Primary Completion

2025-08-19

Completion

2026-02-13

Countries

• United States
• Australia

Study Locations