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

Study acronym: LAP-ST vs ECT
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 12, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 1, 2026 → Oct 1, 2026
See other at-risk trials from Michigan State University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 1, 2026 to Oct 1, 2026
    • Study completion pushed from Nov 1, 2026 to Dec 1, 2026
    • Interventions: Sigma-Stim (Device) to RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) (Procedure), Sigma-Stim (Device)
    v4
  2. Site contact updatedv3
  3. Secondary endpoints: details revised at 3 of 3 entries
    • Study title expanded, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06529029
Lead Sponsor Michigan State University
Collaborators: Pine Rest Christian Mental Health Services
Conditions
(from sponsor)		 Suicidal Ideation, Major Depressive Disorder, Schizo Affective Disorder, Bipolar Disorder
Related terms Bipolar Disorder, Depression, Major Depressive Disorder, Psychotic Disorders, Suicidal Ideation, Suicide
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov