Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 90Years
All Genders
NCT06529029

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

Led by Michigan State University · Updated on 2025-09-16

30

Participants Needed

1

Research Sites

121 weeks

Total Duration

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Sponsors

M

Michigan State University

Lead Sponsor

P

Pine Rest Christian Mental Health Services

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred for ECT by their primary psychiatrist with a valid clinical indication
  • Male or female patients aged 18 to 90 years
  • Current diagnosis of major depressive episode with suicidal ideation in major depressive, bipolar, or schizoaffective disorders
  • Montgomery-Asberg depression rating scale score of 2 or higher on the suicidal ideation item
  • Use of effective birth control for women of child-bearing potential
  • Medically stable patients
  • No need to change psychotropic medications during the study unless urgent
  • Ability to fully participate in the informed consent process
Not Eligible

You will not qualify if you...

  • Unstable or serious medical conditions increasing risks of ECT or cognitive impairment
  • Pregnant or breastfeeding women or those planning pregnancy during the study
  • History of neurological disorders or brain conditions posing risks with ECT
  • Presence of implanted devices that make ECT unsafe
  • Clinical signs of delirium or dementia
  • Active substance use disorder within one week before randomization
  • ECT treatment within the past month or previous failure to respond to an adequate ECT course

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Trial Site Locations

Total: 1 location

1

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, United States, 49548

Actively Recruiting

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Research Team

N

Nagy A Youssef, MD, PhD

CONTACT

J

Janelle M Kassien, LMSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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