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Procedure
Ultrabrief Right Unilateral Electroconvulsive Therapy for Major Depression (RAFT-ECT Trial)
N/A
Recruiting
Led By Vaughn McCall
Research Sponsored by The George Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old
DSM-5 diagnosis of major depressive episode (unipolar or bipolar)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after ect sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Awards & highlights
RAFT-ECT Trial Summary
This trial is testing a new form of electroconvulsive therapy which may have less cognitive side effects than the standard form of the therapy. The trial will last 24 weeks and involve 12 treatments.
Who is the study for?
The RAFT ECT Study is for adults with severe depression who score at least 17 on the HRSD-17 scale, can speak English well enough for testing, and are able to follow study procedures. They must be considered suitable for ECT by their psychiatrist and have a cognitive assessment score of at least 23. Pregnant or breastfeeding women, recent ECT recipients, prisoners, those unable to make medical decisions, or individuals with certain mental health conditions or unstable medical issues cannot participate.Check my eligibility
What is being tested?
This trial compares two types of electroconvulsive therapy (ECT) for major depression: Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) and Frontoparietal UBRUL (UBRUL-FP). Participants will receive random treatments over about four weeks under blinded conditions followed by a six-month observation period. The goal is to see if Frontoparietal placement reduces memory side effects compared to the conventional Temporoparietal approach.See study design
What are the potential side effects?
While ultrabrief right unilateral ECT aims to minimize memory impairment associated with traditional ECT methods, potential side effects may still include short-term confusion post-treatment, headaches, muscle soreness from the induced seizure activity during treatment sessions and some degree of retrograde memory loss.
RAFT-ECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with a major depressive episode.
RAFT-ECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after ect sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after ect sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Change in mean neuropsychological function
+10 moreRAFT-ECT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Frontoparietal ECT GroupExperimental Treatment1 Intervention
Participants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes.
Group II: Temporoparietal ECT GroupActive Control1 Intervention
Participants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes.
Find a Location
Who is running the clinical trial?
Ramsay Clinic Lakeside, AustraliaUNKNOWN
Ramsay Clinic Northside, AustraliaUNKNOWN
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
474,983 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not a prisoner and can make my own medical decisions.I can stop taking certain medications as advised by my psychiatrist.I have a brain condition or injury that significantly affects my thinking, as confirmed by a doctor.I finished a course of ECT in the last 2 months.I am 18 years old or older.My psychiatrist recommends ECT for my depression.I have been diagnosed with a memory disorder or epilepsy by a doctor.I am not pregnant or breastfeeding.I am currently experiencing a manic, hypomanic, or major depressive episode.I have had 8 or more ECT treatments for my current depression without success.I have been diagnosed with a major depressive episode.I have not had electroconvulsive therapy in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Frontoparietal ECT Group
- Group 2: Temporoparietal ECT Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still positions available for interested participants in this clinical experiment?
"According to clinicaltrials.gov, enrollment for this medical trial has been closed since November 7th 2022, when it was last edited. Even though recruitment is not happening currently, 12 other studies are actively looking for participants."
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