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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06529029
The ClinicalTrials.gov registry entry for NCT06529029 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (92% lower). The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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, Suicidal Ideation, Schizo Affective Disorder.
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.
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