RECRUITING

The RAFT ECT Study

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study

Quick Facts

Study Start:2023-03-22

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05402657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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 * 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.

Inclusion Criteria

Exclusion 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)

* 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
* 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.

Contacts and Locations

Study Contact

Rita Barreiros

CONTACT

+61 2 9065 9107

raft-ect.study@unsw.edu.au

Louise Brettell

CONTACT

raft-ect.study@unsw.edu.au

Principal Investigator

Colleen Loo

PRINCIPAL_INVESTIGATOR

University of New South Wales

Anthony Rodgers

PRINCIPAL_INVESTIGATOR

The George Institute

Malcolm Hopwood

PRINCIPAL_INVESTIGATOR

University of Melbourne

Alan Weis

PRINCIPAL_INVESTIGATOR

Newcastle University

Shanthi Sarma

PRINCIPAL_INVESTIGATOR

Gold Coast Hospital and Health Services

Michael Bull

PRINCIPAL_INVESTIGATOR

Ramsay Clinic Lakeside, Warners Bay Private Hospital

Vaughn McCall

PRINCIPAL_INVESTIGATOR

Augusta University

Mark George

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical College of Georgia, Augusta University

Augusta, Georgia, 30912

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: The George Institute

Colleen Loo, PRINCIPAL_INVESTIGATOR, University of New South Wales
Anthony Rodgers, PRINCIPAL_INVESTIGATOR, The George Institute
Malcolm Hopwood, PRINCIPAL_INVESTIGATOR, University of Melbourne
Alan Weis, PRINCIPAL_INVESTIGATOR, Newcastle University
Shanthi Sarma, PRINCIPAL_INVESTIGATOR, Gold Coast Hospital and Health Services
Michael Bull, PRINCIPAL_INVESTIGATOR, Ramsay Clinic Lakeside, Warners Bay Private Hospital
Vaughn McCall, PRINCIPAL_INVESTIGATOR, Augusta University
Mark George, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-22

Study Completion Date2025-07

Study Record Updates

Study Start Date2023-03-22

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Major Depressive Episode