Comparing two types of electroconvulsive therapy for severe depression
The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
This study is testing two different ways of giving electroconvulsive therapy to see which one helps people with severe depression better and has fewer effects on memory.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The George Institute Academic / other |
| Locations | 7 sites (Atlanta, Georgia and 6 other locations) |
| Trial ID | NCT05402657 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and cognitive side effects of two forms of ultrabrief right unilateral electroconvulsive therapy (ECT) for patients with major depressive episodes. One form uses a frontoparietal electrode placement, while the other uses a temporoparietal placement. The study will involve patients diagnosed with severe depression who are indicated for ECT, and it will assess both the effectiveness of the treatments and their impact on memory. This pivotal trial is designed to provide rigorous data that could influence clinical practice regarding ECT.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a DSM-5 diagnosis of major depressive episode who are indicated for ECT.
Not a fit: Patients with a history of schizophrenia, current manic episodes, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective ECT treatment option for patients with severe depression.
How similar studies have performed: Preliminary data suggest that similar approaches have shown promise, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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) 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.
Where this trial is running
Atlanta, Georgia and 6 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Medical College of Georgia, Augusta University — Augusta, Georgia, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Ramsay Clinic Northside — Sydney, New South Wales, Australia (Recruiting)
- Ramsay Clinic Lakeside — Warners Bay, New South Wales, Australia (Recruiting)
- Gold Coast University Hospital (GCUH) — Gold Coast, Queensland, Australia (Recruiting)
- Ramsay Clinic Albert Road — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Colleen Loo — University of New South Wales
- Study coordinator: Rita Barreiros
- Email: raft-ect.study@unsw.edu.au
- Phone: +61 2 9065 9107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.