The RAFT ECT Study

Launched by THE GEORGE INSTITUTE · May 30, 2022

Keywords

ClinConnect Summary

The RAFT ECT Study is investigating a new method of electroconvulsive therapy (ECT) to treat severe depression. While ECT can be very effective, it sometimes causes memory problems. This study focuses on comparing two different ways of delivering a type of ECT called ultrabrief right unilateral (UBRUL) therapy: one using a standard electrode placement (Temporoparietal) and the other using a new placement (Frontoparietal) that may cause fewer memory side effects. The goal is to find out if the new method is just as good at treating depression while being safer for memory.

To participate, individuals must be at least 18 years old and diagnosed with a major depressive episode. They should have moderate to severe depression and be willing to comply with study requirements. The study will involve receiving ECT treatments over about four weeks, with follow-ups lasting 24 weeks after treatment ends. Participants will be randomly assigned to receive either the new or the standard form of ECT. This research is important because it could potentially change how ECT is used in treating severe depression, making it safer and more acceptable for patients.

Gender

ALL

Eligibility 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.