A Phase 2/3 interventional study of Sigma-Stim and RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) in Suicidal Ideation, Major Depressive Disorder and Schizo Affective Disorder, sponsored by Michigan State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Michigan State University · Phase 2/3, Interventional, and Treatment
Among 349 studies in Suicidal Ideation with a site in United States — 109 open to participants now, 122 under way, 4 of them phase 3. Suicidal Ideation · United States.
Among the 349 studies in Suicidal Ideation with a site in United States, this one is the 237th largest by planned enrollment of the 320 interventional ones, is one of 32 that started in 2024, is one of 8 in phase 2/3, reaches primary completion later than 23 of the 121 other live ones, and was the 271st registered.
569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 469 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →109 of the 349 studies in Suicidal Ideation with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 134 Suicidal Ideation studies recruiting now, 51 (38%) set no upper age limit and 79 (59%) stop at 75 or younger; 54 take children under 18; 32 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →349 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 32 started in 2024.
Median enrollment 66 across the 320 interventional studies, 133 across the 29 observational. Of the 198 that completed or were terminated, 82 (41%) have results posted.
24 of 349 have an industry lead sponsor. The 10 most frequent:
Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Michigan State University has 2 studies filed under Suicidal Ideation — fewer than ten, so there is no comparison to draw.
53 of the studies in Suicidal Ideation with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05696691Phase 3The University of Texas Health Science Center at San AntonioKetamine & Crisis Response Plan for Suicidal Ideation in the ED | 2026-12-31 |
| NCT07170657University of Texas Southwestern Medical CenterTeen Recovery Through Inspiration, Support, and Empowerment | 2026-11 |
| NCT06701006University of WashingtonIntegrated Suicide Supports and Safety Planning for Youth | 2026-11-01 |
| NCT06285708Ohio State UniversityEnhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD | 2026-12 |
| NCT05793541Massachusetts General HospitalJust-in-time Interventions for Reducing Short-term Suicide Risk | 2026-12 |
Among the 349 studies in Suicidal Ideation with a site in United States, from their registry updates:
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.
Suicide is one of the leading causes of mortality. Suicidal Ideation (SI) is a precursor to suicide. SI is especially hard to treat/remit in those with treatment-resistant psychiatric disorders (TRPD). This includes treatment-resistant mood disorders and psychotic disorders (such as schizophrenia and schizoaffective disorders). The above TRPD and the SI can remit with Electroconvulsive Therapy (ECT). That is to say, a transdiagnostic, evidence-based treatment for those patients, in addition to pharmacotherapy and psychotherapy, is ECT. ECT has both research support (mainly secondary analysis) and clinical evidence of a beneficial effect in remission of suicidality, as well as unsurpassed effect in treating primary mood and psychotic disorders including those who are treatment-resistant to other therapeutics. However, there are undeniable barriers to treatment with ECT. The most important barrier is memory side effects. ECT can help SI. ECT has also been shown to improve quality of life in a randomized trial by our group, which studied elderly patients with depression. Treating SI, along with the underlying disorder, especially in patients with TRPD is crucial in real-world patients who are clinically referred for ECT. These real-world referrals to ECT (by the patients' primary psychiatrist) will constitute the recruitment pool for this study.
Current amplitude drives electric fields to the deeper structures that are concerned with memory (Peterchev et al., 2010). Previously, the investigators performed the first in human proof of concept one arm open label clinical trial of LAP-ST, (N=22); followed by another small (N=7) pilot randomized, double-blinded clinical trial for the feasibility, safely and initial efficacy of LAP-ST, and another group later confirmed the more favorable cognitive side effects of LAP-ST compared to higher current amplitude (800mA).
However, efficacy of LAP-ST against suicidality has not been well established as primary outcome previously.
Thus, this protocol proposes an initial randomized clinical trial that includes all patients with SI at baseline, and with SI as the primary outcome measure to examine whether RUL LAP-ST treatment has more magnitude and rate of remission of SI as conventional pulse amplitude 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 or 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low Amplitude Pulse Seizure Therapy RUL ECT at 600mA (or 700mA)
Device: Sigma-Stim · Procedure: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)
RUL Conventional pulse amplitude Electroconvulsive Therapy (ECT)
Device: Sigma-Stim
Right Ultra-Brief Low Amplitude Seizure Therapy at 600mA or 700mA vs Right Unilateral Ultra-Brief Standard ECT at 800mA.
Also known as: Low Amplitude Seizure Therapy (LAP-ST)
Please see description above
Suicide Ideation - Self Report
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.
Time frame: Through study completion, an average of four weeks
Suicide Ideation - Clinician Rated
Columbia Suicide Severity Rating Scale (C-SSRS) - clinician administered. Intensity of suicidal ideation: minimum score of 0, maximum score of 5. Lower score indicates a better outcome. Suicidal behavior not rated on a scale.
Time frame: Through study completion, an average of four weeks
Depression - Clinician Rated
Montgomery-Asberg Depression Rating Scale (MADRS) - clinician administered. Minimum score of 0, maximum score of 60. Lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Depression - Self Report
Patient Health Questionnaire (PHQ9) - self reported. Minimum score of 0, maximum score of 27. Lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Depression - Self Report
Quick Inventory of Depressive Symptomatology (QIDS-SR) - self reported. Minimum score of 0, maximum score of 27. Lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Anxiety
Generalized Anxiety Disorder (GAD7) - self reported. Minimum score 0, maximum score 21. Lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Psychosis
Positive and Negative Syndrome Scale (PANSS) - clinician administered. Full scale minimum score of 31. Maximum score of 217. Lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Global Clinical Assessment
Clinical Global Improvement (CGI) - clinician administered. Severity: minimum score of 0, maximum score of 7, lower score indicates better outcome. Improvement: minimum score of 0, maximum score of 7, lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Time to Reorientation after ECT sessions
Time to Reorientation scale (TRO) - study staff administered. Minimum score 3 minutes, maximum score more than 20 minutes. Lower score indicates better outcome.
Time frame: Through study completion, an average of four weeks
Cognitive function and cognitive side effects
Hopkins Verbal Learning Test-Revised (HVLTR) - clinician administered. Minimum score of 0, maximum score of 12. Higher score indicates better outcome.
Time frame: At baseline and completion of the acute ECT/LAP-ST course, an average of four weeks
Cognitive Executive functions
Delis Kaplan Executive Function Scale (DKEFS) - verbal fluency and color/word interference modules - clinician administered. Verbal fluency: minimum score of 1, maximum score of 60. Higher scores indicate better outcome for the total score. Color-word interference: minimum score of 1, maximum score of 19. In general, higher score indicate better outcome.
Time frame: At baseline and completion of the acute ECT/LAP-ST course, an average of four weeks
Autobiographic Memory side effects
Autobiographic Memory Interview-Short Form (AMI-SF) - clinician administered. Minimum score of 0, maximum score of 30. Higher score indicates better outcome.
Time frame: At baseline and completion of the acute ECT/LAP-ST course, an average of four weeks
Plan to share: No
Ran from Jul 2024 to primary completion in Oct 2026, 27 months.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Apr 2027, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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