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Procedure

Low Amplitude Pulse Seizure Therapy for Suicidal Thoughts (LAP-ST vs ECT Trial)

Phase 2 & 3
Recruiting
Led By Nagy A Youssef, MD, PhD
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and completion of the acute ect/lap-st course, an average of four weeks
Awards & highlights

Summary

"This trial aims to compare two treatments for suicidal ideation: Right Unilateral Low-Amplitude Pulse-Seizure Therapy (RUL LAP-ST) and conventional pulse amplitude Right Unilateral Electroconvulsive Therapy

Who is the study for?
This trial is for patients with suicidal thoughts or mood disorders like major depressive disorder, bipolar disorder, psychosis, and schizoaffective disorder. Participants must be experiencing these conditions at the start of the study.
What is being tested?
The trial is testing a new treatment called Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) against standard Right Unilateral Electroconvulsive Therapy (RUL ECT). The focus is on which treatment better reduces suicidal thoughts without causing memory issues.
What are the potential side effects?
While RUL LAP-ST aims to have fewer side effects than conventional RUL ECT, potential risks may include cognitive/memory problems. However, previous studies suggest minimal memory side effects at certain intensities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a major depressive episode as per DSM-5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a serious condition that could worsen with ECT or affect my thinking.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study.
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I have been diagnosed with delirium or dementia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Suicide Ideation - Clinician Rated
Suicide Ideation - Self Report
Secondary study objectives
Depression - Clinician Rated
Depression - Self Report
Other study objectives
Anxiety
Autobiographic Memory side effects
Cognitive Executive functions
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)Experimental Treatment1 Intervention
Low Amplitude Pulse Seizure Therapy RUL ECT at 600mA (or 700mA)
Group II: RUL ECT (Electroconvulsive Therapy)Active Control1 Intervention
RUL Conventional pulse amplitude Electroconvulsive Therapy (ECT)

Find a Location

Who is running the clinical trial?

Pine Rest Christian Mental Health ServicesOTHER
5 Previous Clinical Trials
492 Total Patients Enrolled
Michigan State UniversityLead Sponsor
193 Previous Clinical Trials
669,205 Total Patients Enrolled
1 Trials studying Bipolar Disorder
4 Patients Enrolled for Bipolar Disorder
Nagy A Youssef, MD, PhDPrincipal InvestigatorPine Rest Christian Mental Health Services & Michigan State University
~20 spots leftby Jul 2026
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