Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy

Recruiting now · Phase 2/Phase 3

Conditions studied: Suicidal Ideation, Major Depressive Disorder, Schizo Affective Disorder, Bipolar Disorder

In brief

This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.

Key facts

Study ID

NCT06529029

Run by

Michigan State University

People needed

30

Starts

2024-07-03

Expected to finish

2026-11-01

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.
• Male or female patients 18 to 90 years of age
• Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
• Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item
• Use of effective method of birth control for women of child-bearing capacity
• Patient is medically stable
• No anticipated need to alter psychotropic medications for the duration of the study (except for urgent/emergent situations)
• Ability of patient to fully participate in the informed consent process

You may not qualify if…

• Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment
• Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding
• History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment
• Implanted devices that make ECT unsafe
• Clinical presentation of delirium or dementia
• Active substance use disorders within 1 week of randomization
• ECT in the past 1 month or prior failure to respond to an adequate course of ECT as deemed by the ECT physician treating the patient or the PI

Where it is running

• Pine Rest Christian Mental Health Services — Grand Rapids, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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