Status:
RECRUITING
The RAFT ECT Study
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Ramsay Clinic Albert Road, Australia
Conditions:
Major Depressive Episode
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 depressio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05402657
Start Date
March 22 2023
End Date
January 1 2026
Last Update
April 11 2025
Active Locations (7)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Medical College of Georgia, Augusta University
Augusta, Georgia, United States, 30912
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
Ramsay Clinic Northside
Sydney, New South Wales, Australia, 2065