Research Aims and Hypotheses:
The main aim of this proposal is to examine if Right Unilateral (RUL) Low Amplitude Pulse Seizure Therapy (LAP-ST) (which has been shown in our proof of concept studies to have less or no memory and cognitive side effects compared to standard ECT) will improve suicidal ideations (SI, primary outcome) to a greater magnitude than conventional pulse amplitude RUL Electroconvulsive Therapy (ECT) in patients clinically referred to ECT for Major Depressive Episode (MDE). Our hypothesis is that RUL LAP-ST will improve SI to a greater magnitude (based on prior secondary analysis of pilot data), as measured by the suicide item of the Montgomery Asberg Depression Scale, compared to RUL conventional amplitude ECT in patients referred to ECT for MDE. We will also examine if RUL LAP-ST will improve suicidal ideations faster than ECT (secondary outcome).
Sample:
Thirty male and female patients with SI and in a MDE (15 in each arm) who are referred clinically for ECT will be recruited.
Measures:
MINI interview (DSM 5 version for diagnoses), Beck Scale of Suicidal Ideation/Worst (SSI/W), Montgomer Asberg Depression Rating Scale (MADRS), Columbia-Suicide Severity Rating Scale, Clinical Global Improvement Scale, Quick Inventory of Depressive Symptomatology (Self-Report), Patient Health Questionnaire (Self-Report). Neuropsychological Battery will include: Time to Orientation test (one of the best tests to predict of memory side effects associated with ECT), Hopkins Verbal Learning Test-Revised retention raw score, Delis Kaplan Executive Function, Autobiographic Memory Interview-Short form, among others.
Procedures:
Participants will be recruited from referrals to The Ohio State University ECT service. Participants who meet the enrollment criteria will be randomized parallel-design (1:1 ratio) to RUL LAP-ST or standard amplitude RUL ultra-brief ECT course. The study will be double-blinded. Primary outcome will be measured at baseline, end of the study and prior to every ECT/LAP-ST session. Patients will receive the pre-ECT workup as per usual clinical care for safe delivery of ECT and anesthetic procedures.
Impact: Firstly, this will help spur new developments in ECT and LAP toward treatment and prevention of suicide in the highest risk population referred to ECT. Secondly, it will help add to our limited knowledge of reducing (or almost eliminating) memory and cognitive side effects of this most effective modality of treatment, and toward better depression treatments.
Next Steps:
If findings are positive, we will perform randomized studies in a larger sample to replicate and confirm the findings, and to detect smaller differences between groups. We will also work toward identifying targets for SI using functional MRI and other techniques, as next steps. If results are negative (i.e., LAP-ST have less, not more, anti-suicide effect than standard ECT), we will learn why and move to next steps of identifying targets and examine if smaller differences may explain the apparent negative results. We will also gain more insight and add to the limited data about reducing memory side effects, which may have added indirect and direct benefits on suicide prevention in the long run, as cognitive impairment may also increase suicide rate.
