The RAFT ECT Study
Purpose
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.
Condition
- Major Depressive Episode
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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, 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- Participants and outcome assessors completing assessments of mood (primary outcome) will be blinded to the participant's treatment allocation until the database is locked and the primary analysis completed. Hospital ward personnel, if not involved in the delivery of ECT, will also be blinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- The George Institute
