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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

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
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.
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
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.
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
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.
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)
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.
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)
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).
Timepoint [4] 0 0
Through the randomized acute ECT treatment period (typically 4 weeks)
Secondary outcome [5] 0 0
Suicidality score
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
Timepoint [5] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [6] 0 0
Post ECT reorientation time
Assessment method [6] 0 0
Post ECT reorientation time is the time taken to recover orientation immediately after ECT in randomised treatment phase.
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
Assessment method [7] 0 0
Assessed by a cognitive test battery.
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)
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.
Timepoint [8] 0 0
From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcome [9] 0 0
Number of responders
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
Timepoint [9] 0 0
From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Secondary outcome [10] 0 0
Number of remitters
Assessment method [10] 0 0
Remission is defined as a score of = 7 on the Hamilton Rating Scale for Depression-17.
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
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.
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)
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.
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
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).
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
* 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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Ramsay Clinic Albert Road, Australia
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ramsay Clinic Lakeside, Australia
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Ramsay Clinic Northside, Australia
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Gold Coast Hospital and Health Service
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Augusta University
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Medical University of South Carolina
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
The University of New South Wales
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Emory University
Country [9] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo
Address 0 0
University of New South Wales
Country 0 0
Phone 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
Email 0 0
raft-ect.study@unsw.edu.au
Contact person for scientific queries

Data sharing statement


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