Amplitude Titration to Improve Electroconvulsive Therapy Clinical Outcomes Randomized Trial

What this Trial Is About

Researchers are evaluating the effects of individualized amplitude versus fixed 800 mA amplitude electroconvulsive therapy (ECT) on hippocampal neuroplasticity, antidepressant response, and cognitive outcomes in older adults with depression. This randomized controlled trial aims to determine if individualized amplitude dosing can improve antidepressant outcomes and cognitive function compared to traditional fixed amplitude ECT. The study focuses on right unilateral (RUL) electrode placement and includes participants diagnosed with major depressive disorder or bipolar II disorder. Participants will be randomly assigned to receive ECT with either an individualized amplitude determined by seizure titration and electric field modeling or a fixed amplitude of 800 mA. Both groups will receive the same pulse width, frequency, and pulse train duration during treatments. The individualized amplitude is adjusted using a device called the Soterix Medical Incorporated 4x1 adapter, while the fixed amplitude group uses a traditional FDA-approved ECT device. Assessments will occur at baseline, after six ECT treatments, and after the full ECT series, with potential switch to bitemporal electrode placement if improvement is insufficient. During the trial, participants will undergo clinical assessments including the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) and neuropsychological testing using the Delis Kaplan Executive Function System Verbal Fluency (DKEFS). Imaging and other clinical evaluations will be done before the first ECT session and at follow-up visits. The study measures antidepressant response and cognitive changes, with safety and treatment adherence monitored throughout. The total participation duration spans from baseline through the completion of the ECT series and final assessments.

Amplitude Titration to Improve ECT Clinical Outcomes