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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05402657




Registration number
NCT05402657
Ethics application status
Date submitted
5/05/2022
Date registered
2/06/2022
Date last updated
5/10/2023

Titles & IDs
Public title
The RAFT ECT Study
Scientific title
The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
Secondary ID [1] 0 0
APP1159769
Secondary ID [2] 0 0
X22-0018
Universal Trial Number (UTN)
Trial acronym
RAFT-ECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Episode 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy
Treatment: Surgery - Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy

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.


Treatment: Surgery: 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.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Timepoint [1] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [1] 0 0
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Timepoint [1] 0 0
From end of acute ECT treatment up to 24-week follow-up
Secondary outcome [2] 0 0
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
Timepoint [2] 0 0
From Baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [3] 0 0
Clinical Global Impression-Severity (CGI-S)
Timepoint [3] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [4] 0 0
Clinical Global Impression-Improvement (CGI-I)
Timepoint [4] 0 0
Through the randomized acute ECT treatment period (typically 4 weeks)
Secondary outcome [5] 0 0
Suicidality score
Timepoint [5] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [6] 0 0
Post ECT reorientation time
Timepoint [6] 0 0
After ECT sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Secondary outcome [7] 0 0
Change in mean neuropsychological function
Timepoint [7] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [8] 0 0
Mental Health Questionnaire-14 (MHQ-14)
Timepoint [8] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [9] 0 0
Number of responders
Timepoint [9] 0 0
From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Secondary outcome [10] 0 0
Number of remitters
Timepoint [10] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [11] 0 0
Number of participants switched from randomized treatment to another form of acute ECT
Timepoint [11] 0 0
After at least 8 randomized ECT treatments (typically after 3 weeks).
Secondary outcome [12] 0 0
Number of randomized ECT treatments given over the Acute Study Treatment Phase (RCT)
Timepoint [12] 0 0
From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Secondary outcome [13] 0 0
Occurrence of adverse events and serious adverse events
Timepoint [13] 0 0
From baseline and up to 24-week follow-up

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Ramsay Clinic Northside - Sydney
Recruitment hospital [2] 0 0
Ramsay Clinic Lakeside - Warners Bay
Recruitment hospital [3] 0 0
Gold Coast University Hospital (GCUH) - Gold Coast
Recruitment hospital [4] 0 0
Ramsay Clinic Albert Road - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
2282 - Warners Bay
Recruitment postcode(s) [3] 0 0
4215 - Gold Coast
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Ramsay Clinic Albert Road, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ramsay Clinic Lakeside, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Ramsay Clinic Northside, Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Gold Coast Hospital and Health Service
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Augusta University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Medical University of South Carolina
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
The University of New South Wales
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT05402657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rita Barreiros
Address 0 0
Country 0 0
Phone 0 0
+61 2 9065 9107
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05402657