Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Titles & IDs
Public title
The RAFT ECT Study
Query!
Scientific title
The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
Query!
Secondary ID [1]
0
0
APP1159769
Query!
Secondary ID [2]
0
0
X22-0018
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RAFT-ECT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Major Depressive Episode
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Query!
Assessment method [1]
0
0
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
Query!
Timepoint [1]
0
0
From baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [1]
0
0
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Query!
Assessment method [1]
0
0
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
Query!
Timepoint [1]
0
0
From end of acute ECT treatment up to 24-week follow-up
Query!
Secondary outcome [2]
0
0
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
Query!
Assessment method [2]
0
0
In the Autobiographical Memory Interview-Short Form, participants are graded on the consistency of their answers between baseline and subsequent time-points. The maximum consistency score is 100 percent, with lower percentages representing increasing inconsistency in retrospective autobiographical memory function.
Query!
Timepoint [2]
0
0
From Baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [3]
0
0
Clinical Global Impression-Severity (CGI-S)
Query!
Assessment method [3]
0
0
The Clinical Global Impression-Severity measure is a 7-point scale where a clinician rates the severity of a patient's illness in comparison to the clinician's experience with patients who have the same diagnosis. The ratings range from 1 indicating normal, not at all ill to 7 suggesting they are among the most extremely ill patients.
Query!
Timepoint [3]
0
0
From baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [4]
0
0
Clinical Global Impression-Improvement (CGI-I)
Query!
Assessment method [4]
0
0
The Clinical Global Impression-Improvement is a measure where a clinician assesses how much the patient's illness has improved or worsened in comparison to baseline. The "improved" version being used in this trial (Kadouri, Corruble \& Falissard, 2007) is a 13-point scale with ratings which range from 6 ('ideal improvement') to -6 (maximum deterioration).
Query!
Timepoint [4]
0
0
Through the randomized acute ECT treatment period (typically 4 weeks)
Query!
Secondary outcome [5]
0
0
Suicidality score
Query!
Assessment method [5]
0
0
Assessed by examining scores on item 3 (suicidality) of the Hamilton Rating Scale for Depression (which range from 0 to 4, where higher scores indicate more severe and/or persistent suicidality) and scores on the suicidal ideation subscale of the Columbia
Query!
Timepoint [5]
0
0
From baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [6]
0
0
Post ECT reorientation time
Query!
Assessment method [6]
0
0
Post ECT reorientation time is the time taken to recover orientation immediately after ECT in randomised treatment phase.
Query!
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.
Query!
Secondary outcome [7]
0
0
Change in mean neuropsychological function
Query!
Assessment method [7]
0
0
Assessed by a cognitive test battery.
Query!
Timepoint [7]
0
0
From baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [8]
0
0
Mental Health Questionnaire-14 (MHQ-14)
Query!
Assessment method [8]
0
0
The Mental Health Questionnaire-14 is a self-report quality of life instrument consisting of the mental health component of the Medical Outcomes Study questionnaire. This patient self-report measure contains 14 items in total, addressing symptoms of fatigue, anxiety and depression, and the impact of these symptoms on functioning. Scores on this measure range from 0 to 100, where higher scores indicate better quality of life.
Query!
Timepoint [8]
0
0
From baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [9]
0
0
Number of responders
Query!
Assessment method [9]
0
0
Response is defined as a 50 percent reduction in depression severity from baseline, assessed using the Hamilton Rating Scale for Depression-17
Query!
Timepoint [9]
0
0
From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Query!
Secondary outcome [10]
0
0
Number of remitters
Query!
Assessment method [10]
0
0
Remission is defined as a score of = 7 on the Hamilton Rating Scale for Depression-17.
Query!
Timepoint [10]
0
0
From baseline to end of randomized acute treatment (typically 4 weeks)
Query!
Secondary outcome [11]
0
0
Number of participants switched from randomized treatment to another form of acute ECT
Query!
Assessment method [11]
0
0
Number of participants switched from randomized treatment to another form of acute ECT after receiving at least 8 randomized ECT.
Query!
Timepoint [11]
0
0
After at least 8 randomized ECT treatments (typically after 3 weeks).
Query!
Secondary outcome [12]
0
0
Number of randomized ECT treatments given over the Acute Study Treatment Phase (RCT)
Query!
Assessment method [12]
0
0
Number of randomized acute ECT treatments received by participants during the Acute Study Treatment Phase (RCT), compared between the groups.
Query!
Timepoint [12]
0
0
From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Query!
Secondary outcome [13]
0
0
Occurrence of adverse events and serious adverse events
Query!
Assessment method [13]
0
0
Occurrence of adverse events (AEs) and serious adverse events (SAEs) compared between the groups, based on treating them as binary outcomes (no/yes, e.g., whether participants experienced any given side effect/adverse event at least once) and as count outcomes (number of occurrences).
Query!
Timepoint [13]
0
0
From baseline and up to 24-week follow-up
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
22/03/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2025
Query!
Actual
Query!
Sample size
Target
154
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Ramsay Clinic Northside - Sydney
Query!
Recruitment hospital [2]
0
0
Ramsay Clinic Lakeside - Warners Bay
Query!
Recruitment hospital [3]
0
0
Gold Coast University Hospital (GCUH) - Gold Coast
Query!
Recruitment hospital [4]
0
0
Ramsay Clinic Albert Road - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2065 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
2282 - Warners Bay
Query!
Recruitment postcode(s) [3]
0
0
4215 - Gold Coast
Query!
Recruitment postcode(s) [4]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
South Carolina
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The George Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
National Health and Medical Research Council, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Ramsay Clinic Albert Road, Australia
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Ramsay Clinic Lakeside, Australia
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
Ramsay Clinic Northside, Australia
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Government body
Query!
Name [5]
0
0
Gold Coast Hospital and Health Service
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Other collaborator category [6]
0
0
Other
Query!
Name [6]
0
0
Augusta University
Query!
Address [6]
0
0
Query!
Country [6]
0
0
Query!
Other collaborator category [7]
0
0
Other
Query!
Name [7]
0
0
Medical University of South Carolina
Query!
Address [7]
0
0
Query!
Country [7]
0
0
Query!
Other collaborator category [8]
0
0
Other
Query!
Name [8]
0
0
The University of New South Wales
Query!
Address [8]
0
0
Query!
Country [8]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05402657
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Colleen Loo
Query!
Address
0
0
University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Rita Barreiros
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 2 9065 9107
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05402657