Mental Disorders, Cognitive Impairment and the Risk of Suicide in Older Adults.
Agnieszka Kułak-Bejda, Grzegorz Bejda, Napoleon Waszkiewicz
https://pubmed.ncbi.nlm.nih.gov/34512415/Actively Recruiting
Led by Michigan State University · Updated on 2026-08-12
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
This research aims to compare two forms of electroconvulsive therapy ECT for patients experiencing suicidal thoughts, particularly those with treatment-resistant psychiatric disorders such as major depressive disorder, bipolar disorder, and schizoaffective disorder. The study focuses on whether Right Unilateral Low-Amplitude Pulse Seizure Therapy RUL LAP-ST offers a better remission rate of suicidal ideation compared to standard Right Unilateral Electroconvulsive Therapy RUL ECT, while potentially causing fewer memory and cognitive side effects. This trial includes adult patients referred for ECT due to suicidal ideation and related mood or psychotic disorders. Participants will be randomly assigned to receive either RUL LAP-ST at 600mA or 700mA or the conventional RUL ECT at 800mA. The study uses devices such as Sigma-Stim to deliver these treatments. Both treatments involve ultra-brief pulse amplitude seizure therapy, with the trial designed to evaluate the differences in effectiveness and side effects over an average treatment period of four weeks. The study is double-blinded and includes a parallel design comparing these two arms. During the study, participants will be monitored through self-reports and clinician assessments focusing on suicidal ideation and depression levels. Various scales, including the Montgomery-Asberg Depression Rating Scale, will be used to measure outcomes. The study aims to assess remission of suicidal ideation as the primary outcome alongside secondary depression outcomes. Participants will remain in the study for about four weeks, during which their cognitive effects and safety will be closely observed. The trial is sponsored by Michigan State University and runs until December 2026.
CONDITIONS
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
N
Nagy A Youssef, MD, PhD
J
Janelle M Kassien, LMSW
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Michigan State University
Lead Sponsor
Pine Rest Christian Mental Health Services
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Low-Amplitude Pulse Seizure Therapy (LAP-ST) | Standard Ultra-Brief Right Unilateral ECT |
|---|---|---|
| What it is | Low-Amplitude Pulse Seizure Therapy (LAP-ST) is an investigational form of electroconvulsive therapy using right unilateral, ultra-brief pulse electrical stimulation delivered at either 600 or 700mA (lower than standard), designed to minimize cognitive side effects while inducing therapeutic seizures. | Standard right unilateral ultra-brief pulse ECT applies electrical stimulation at 800mA to induce therapeutic seizures for the treatment of severe mood disorders with suicidality. |
| Role in trial | Tested as the investigational device/procedure arm to evaluate whether reduced amplitude leads to similar therapeutic benefit but better cognitive outcomes. | Serves as the active comparator arm reflecting the current standard-of-care ECT dosing used for eligible patients. |
| Primary use | Explored for reducing suicidal ideation and depressive symptoms in adults with severe major depressive disorder, bipolar disorder, or schizoaffective disorder referred for ECT. | Standard ECT is used to rapidly reduce suicidality and severe depressive symptoms in patients for whom ECT is indicated. |
| How it is given/performed | Delivered in a hospital setting under anesthesia, right-unilateral electrode placement, with electrical amplitude set at 600 or 700mA. Frequency and dose adjustments per protocol. | Given in hospital under anesthesia, with right-unilateral ultra-brief pulse stimulation at 800mA, according to standard clinical protocols for ECT. |
| Evidence status | Preliminary clinical studies suggest that LAP-ST may lead to remission of suicidality while aiming for reduced cognitive side effects compared to standard ECT, but large-scale, long-term data remain limited. | Standard right unilateral ultra-brief pulse ECT has substantial evidence supporting its effectiveness for rapidly reducing suicidality and depressive symptoms in severe mood disorders. |
| Important risks | Preliminary data indicate potential for reduced cognitive side effects compared to standard ECT, but definitive safety risks remain under investigation and all standard risks of ECT still apply (e.g., transient confusion, memory impairment, anesthesia risk). | Routine risks of ECT include temporary memory impairment, confusion, headache, and anesthesia-related complications. Cognitive effects vary between individuals and settings. |
| Important limitations | As an investigational therapy, LAP-ST has limited clinical evidence with small study sizes, short follow-up, and ongoing research regarding long-term cognitive and clinical outcomes. | While ECT is well studied, cognitive side effects can impact quality of life and there is variability in long-term memory changes; individual tolerance and response also vary. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 weeks
Participants receive either Low-Amplitude Pulse Seizure Therapy or standard Right Unilateral Electroconvulsive Therapy using the Sigma-Stim device.
Regular visits during treatment period
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/469082/Michigan State University
Lead Sponsor
Pine Rest Christian Mental Health Services
Collaborating Sponsor