Suicidal IdeationPhase 2/3LAP-ST vs ECTNCT06529029
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
A Phase 2/3 study testing Sigma-Stim and RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) in people with Suicidal Ideation and Major Depressive Disorder, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Suicidal Ideation, Major Depressive Disorder, Schizo Affective Disorder
- What is being tested?
- Sigma-Stim and RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.
- Male or female patients 18 to 90 years of age
- Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
- Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item
- Use of effective method of birth control for women of child-bearing capacity
- Patient is medically stable
- No anticipated need to alter psychotropic medications for the duration of the study (except for urgent/emergent situations)
- Ability of patient to fully participate in the informed consent process
Who cannot join
- 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
- History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment
- Implanted devices that make ECT unsafe
- Clinical presentation of delirium or dementia
- Active substance use disorders within 1 week of randomization
- ECT in the past 1 month or prior failure to respond to an adequate course of ECT as deemed by the ECT physician treating the patient or the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
About this study
Official title: Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation
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.
Read the detailed description
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.
- Being tested
- Sigma-Stim, RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)
- Keywords
- Suicidal Ideation, Suicide, Depression, Major Depressive Disorder, Schizo Affective Disorder, Bipolar Disorder, Low Amplitude Seizure Therapy, Electroconvulsive Therapy, Neuromodulation, Brain Stimulation
- Medical subject headings
- Suicidal Ideation, Depressive Disorder, Major, Psychotic Disorders, Bipolar Disorder, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigma-StimDevice
Also called Low Amplitude Seizure Therapy (LAP-ST)
Right Ultra-Brief Low Amplitude Seizure Therapy at 600mA or 700mA vs Right Unilateral Ultra-Brief Standard ECT at 800mA.
RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)Procedure or surgery
Please see description above
| Study group | Role | What they receive |
|---|---|---|
| RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) | Experimental | Low Amplitude Pulse Seizure Therapy RUL ECT at 600mA (or 700mA) Receives: Device: Sigma-Stim; Procedure: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) |
| RUL ECT (Electroconvulsive Therapy) | Active comparator | RUL Conventional pulse amplitude Electroconvulsive Therapy (ECT) Receives: Device: Sigma-Stim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of four weeks
Secondary outcomes (3)
Depression - Clinician Rated
Montgomery-Asberg Depression Rating Scale (MADRS) - clinician administered. Minimum score of 0, maximum score of 60. Lower score indicates better outcome.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start3 Jul 2024
- Primary completion8 Oct 2026
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Pine Rest Christian Mental Health Services
- Responsible party
- Principal investigator, Nagy Youssef, MD, PhD, Michigan State University
- Investigators
- Nagy A Youssef, MD, PhD, Principal investigator, Pine Rest Christian Mental Health Services & Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529029
- Sponsor's protocol ID
- STUDY00010089
- Acronym
- LAP-ST vs ECT
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kochanek KD, Murphy S, Xu J, Arias E. Mortality in the United States, 2016. NCHS Data Brief. 2017 Dec;(293):1-8.
PubMed 29319473Curtin S, Warner M, Hedegaard H: Increase in suicide in the United States, 1999-2014. NCHS data brief no. 241. Hyattsville, MD: US Department of Health and Human Services, CDC, National Center for Health Statistics. https://www.cdc.gov/nchs/data/databriefs/db241.pdf. 2016
Kellner CH, Fink M, Knapp R, Petrides G, Husain M, Rummans T, Mueller M, Bernstein H, Rasmussen K, O'connor K, Smith G, Rush AJ, Biggs M, McClintock S, Bailine S, Malur C. Relief of expressed suicidal intent by ECT: a consortium for research in ECT study. Am J Psychiatry. 2005 May;162(5):977-82. doi: 10.1176/appi.ajp.162.5.977.
PubMed 15863801Fink M, Kellner CH, McCall WV. The role of ECT in suicide prevention. J ECT. 2014 Mar;30(1):5-9. doi: 10.1097/YCT.0b013e3182a6ad0d.
PubMed 24091903Sienaert P. Based on a True Story? The Portrayal of ECT in International Movies and Television Programs. Brain Stimul. 2016 Nov-Dec;9(6):882-891. doi: 10.1016/j.brs.2016.07.005. Epub 2016 Jul 20.
PubMed 27522170McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Youssef NA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial. J Psychiatr Res. 2018 Feb;97:65-69. doi: 10.1016/j.jpsychires.2017.11.001. Epub 2017 Nov 16.
PubMed 29195125Kulak-Bejda A, Bejda G, Waszkiewicz N. Mental Disorders, Cognitive Impairment and the Risk of Suicide in Older Adults. Front Psychiatry. 2021 Aug 25;12:695286. doi: 10.3389/fpsyt.2021.695286. eCollection 2021.
PubMed 34512415Lara E, Olaya B, Garin N, Ayuso-Mateos JL, Miret M, Moneta V, Haro JM. Is cognitive impairment associated with suicidality? A population-based study. Eur Neuropsychopharmacol. 2015 Feb;25(2):203-13. doi: 10.1016/j.euroneuro.2014.08.010. Epub 2014 Aug 21.
PubMed 25190638Fernandez-Sevillano J, Alberich S, Zorrilla I, Gonzalez-Ortega I, Lopez MP, Perez V, Vieta E, Gonzalez-Pinto A, Saiz P. Cognition in Recent Suicide Attempts: Altered Executive Function. Front Psychiatry. 2021 Jul 22;12:701140. doi: 10.3389/fpsyt.2021.701140. eCollection 2021.
PubMed 34366931Rutter SB, Cipriani N, Smith EC, Ramjas E, Vaccaro DH, Martin Lopez M, Calabrese WR, Torres D, Campos-Abraham P, Llaguno M, Soto E, Ghavami M, Perez-Rodriguez MM. Neurocognition and the Suicidal Process. Curr Top Behav Neurosci. 2020;46:117-153. doi: 10.1007/7854_2020_162.
PubMed 32860213Szanto K, Galfalvy H, Vanyukov PM, Keilp JG, Dombrovski AY. Pathways to Late-Life Suicidal Behavior: Cluster Analysis and Predictive Validation of Suicidal Behavior in a Sample of Older Adults With Major Depression. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11611. doi: 10.4088/JCP.17m11611.
PubMed 29489076Deng ZD, Lisanby SH, Peterchev AV. Electric field strength and focality in electroconvulsive therapy and magnetic seizure therapy: a finite element simulation study. J Neural Eng. 2011 Feb;8(1):016007. doi: 10.1088/1741-2560/8/1/016007. Epub 2011 Jan 19.
PubMed 21248385Peterchev AV, Rosa MA, Deng ZD, Prudic J, Lisanby SH. Electroconvulsive therapy stimulus parameters: rethinking dosage. J ECT. 2010 Sep;26(3):159-74. doi: 10.1097/YCT.0b013e3181e48165.
PubMed 20805726Youssef N, Sidhom E: Examination of Cognitive Profile and Variability in the Current Amplitude Domain of Low Current Amplitude ECT in Society of Biological Psychiatry 69th Annual Meeting (Published in Biological Psychiatry 2014 supplement) New York, New York2014
Youssef NA, Sidhom E. Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in man. J Affect Disord. 2017 Nov;222:1-6. doi: 10.1016/j.jad.2017.06.022. Epub 2017 Jun 16.
PubMed 28667887
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation
- ClinicalTrials.gov ID
- NCT06529029
- Acronym / sponsor ID
- LAP-ST vs ECT / STUDY00010089
- Keywords
- Suicidal Ideation, Suicide, Depression, Major Depressive Disorder, Schizo Affective Disorder, Bipolar Disorder, Low Amplitude Seizure Therapy, Electroconvulsive Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Pine Rest Christian Mental Health Services
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 8 Oct 2026 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) | Experimental | Device: Sigma-Stim, Procedure: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)Low Amplitude Pulse Seizure Therapy RUL ECT at 600mA (or 700mA) |
| RUL ECT (Electroconvulsive Therapy) | Active comparator | Device: Sigma-StimRUL Conventional pulse amplitude Electroconvulsive Therapy (ECT) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.
- Male or female patients 18 to 90 years of age
- Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
- Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item
- Use of effective method of birth control for women of child-bearing capacity
Key exclusion criteria (7 listed)
- 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
- History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment
- Implanted devices that make ECT unsafe
- Clinical presentation of delirium or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigma-StimAlso: Low Amplitude Seizure Therapy (LAP-ST)Right Ultra-Brief Low Amplitude Seizure Therapy at 600mA or 700mA vs Right Unilateral Ultra-Brief Standard ECT at 800mA. | Device | RUL ECT (Electroconvulsive Therapy), RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) |
| RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)Please see description above | Procedure or surgery | RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) |
Primary outcome
Suicide Ideation - Self Report
Time frame: Through study completion, an average of four weeks
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.
Suicide Ideation - Clinician Rated
Time frame: Through study completion, an average of four weeks
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.
3 secondary outcomes
Depression - Clinician Rated
Time frame: Through study completion, an average of four weeks
Depression - Self Report
Time frame: Through study completion, an average of four weeks
Depression - Self Report
Time frame: Through study completion, an average of four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 29319473Kochanek KD, Murphy S, Xu J, Arias E. Mortality in the United States, 2016. NCHS Data Brief. 2017 Dec;(293):1-8.
- BackgroundCurtin S, Warner M, Hedegaard H: Increase in suicide in the United States, 1999-2014. NCHS data brief no. 241. Hyattsville, MD: US Department of Health and Human Services, CDC, National Center for Health Statistics. https://www.cdc.gov/nchs/data/databriefs/db241.pdf. 2016
- Background: PubMed 15863801Kellner CH, Fink M, Knapp R, Petrides G, Husain M, Rummans T, Mueller M, Bernstein H, Rasmussen K, O'connor K, Smith G, Rush AJ, Biggs M, McClintock S, Bailine S, Malur C. Relief of expressed suicidal intent by ECT: a consortium for research in ECT study. Am J Psychiatry. 2005 May;162(5):977-82. doi: 10.1176/appi.ajp.162.5.977.
- Background: PubMed 24091903Fink M, Kellner CH, McCall WV. The role of ECT in suicide prevention. J ECT. 2014 Mar;30(1):5-9. doi: 10.1097/YCT.0b013e3182a6ad0d.
- Background: PubMed 27522170Sienaert P. Based on a True Story? The Portrayal of ECT in International Movies and Television Programs. Brain Stimul. 2016 Nov-Dec;9(6):882-891. doi: 10.1016/j.brs.2016.07.005. Epub 2016 Jul 20.
- Background: PubMed 29195125McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Youssef NA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial. J Psychiatr Res. 2018 Feb;97:65-69. doi: 10.1016/j.jpsychires.2017.11.001. Epub 2017 Nov 16.
- Background: PubMed 34512415Kulak-Bejda A, Bejda G, Waszkiewicz N. Mental Disorders, Cognitive Impairment and the Risk of Suicide in Older Adults. Front Psychiatry. 2021 Aug 25;12:695286. doi: 10.3389/fpsyt.2021.695286. eCollection 2021.
- Background: PubMed 25190638Lara E, Olaya B, Garin N, Ayuso-Mateos JL, Miret M, Moneta V, Haro JM. Is cognitive impairment associated with suicidality? A population-based study. Eur Neuropsychopharmacol. 2015 Feb;25(2):203-13. doi: 10.1016/j.euroneuro.2014.08.010. Epub 2014 Aug 21.
- Background: PubMed 34366931Fernandez-Sevillano J, Alberich S, Zorrilla I, Gonzalez-Ortega I, Lopez MP, Perez V, Vieta E, Gonzalez-Pinto A, Saiz P. Cognition in Recent Suicide Attempts: Altered Executive Function. Front Psychiatry. 2021 Jul 22;12:701140. doi: 10.3389/fpsyt.2021.701140. eCollection 2021.
- Background: PubMed 32860213Rutter SB, Cipriani N, Smith EC, Ramjas E, Vaccaro DH, Martin Lopez M, Calabrese WR, Torres D, Campos-Abraham P, Llaguno M, Soto E, Ghavami M, Perez-Rodriguez MM. Neurocognition and the Suicidal Process. Curr Top Behav Neurosci. 2020;46:117-153. doi: 10.1007/7854_2020_162.
- Background: PubMed 29489076Szanto K, Galfalvy H, Vanyukov PM, Keilp JG, Dombrovski AY. Pathways to Late-Life Suicidal Behavior: Cluster Analysis and Predictive Validation of Suicidal Behavior in a Sample of Older Adults With Major Depression. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11611. doi: 10.4088/JCP.17m11611.
- Background: PubMed 21248385Deng ZD, Lisanby SH, Peterchev AV. Electric field strength and focality in electroconvulsive therapy and magnetic seizure therapy: a finite element simulation study. J Neural Eng. 2011 Feb;8(1):016007. doi: 10.1088/1741-2560/8/1/016007. Epub 2011 Jan 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagy A Youssef, MD, PhD principal investigator
Pine Rest Christian Mental Health Services & Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sigma-Stim and RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) in people with Suicidal Ideation and Major Depressive Disorder, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Ideation - Self Report (time frame: Through study completion, an average of four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06529029, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.