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NCT06529029 · ClinicalTrials.gov registry record · Phase 2
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
A Phase 2 study of Major Depressive Disorder and Bipolar Disorder, sponsored by Michigan State University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06529029: Recruiting Phase 2 study of Major Depressive Disorder and Bipolar Disorder, sponsored by Michigan State University.
NCT06529029 is a Phase 2 study of Major Depressive Disorder and Bipolar Disorder that is actively recruiting participants, run by Michigan State University. The registered enrollment target is 30 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06529029, a Phase 2 study of Major Depressive Disorder and Bipolar Disorder, is actively recruiting participants, sponsored by Michigan State University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Beck Scale for Suicide Ideation (SSI-Worst and SSI-Current) - self reported. Minimum score of 0, maximum score of 42. Lower score indicates a better outcome.
Conditions Studied
Interventions
- DEVICE Sigma-Stim
Study Locations (1)
Michigan
- Pine Rest Christian Mental Health Services - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-07-03 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 2 |
What NCT06529029 shows while recruiting
NCT06529029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Sigma-Stim is the first listed.
NCT06529029 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06529029 about?
NCT06529029 is a clinical study titled "Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy". 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 r...
What is the current status of trial NCT06529029?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-07-03. Estimated completion is 2026-11-01.
What conditions does trial NCT06529029 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Bipolar Disorder, Schizoaffective Disorder, Suicidal Ideation.
What interventions are being tested in trial NCT06529029?
The interventions under investigation include: Sigma-Stim (DEVICE).
Who is sponsoring clinical trial NCT06529029?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06529029 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06529029's enrollment target sits among peer trials
30 220th of 282 higher than 56 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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