Comparing Low Amplitude Pulse Seizure Therapy to Standard Electroconvulsive Therapy for Suicidal Ideation
Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation
This study is testing a new type of seizure therapy to see if it can help people with severe depression and suicidal thoughts feel better while causing fewer side effects than standard treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Michigan State University Academic / other |
| Locations | 1 site (Grand Rapids, Michigan) |
| Trial ID | NCT06529029 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Right Unilateral Low-Amplitude Pulse Seizure Therapy (RUL LAP-ST) compared to conventional Right Unilateral Electroconvulsive Therapy (RUL ECT) in patients experiencing suicidal ideation. The study focuses on individuals with treatment-resistant psychiatric disorders, including major depressive disorder, bipolar disorder, and schizoaffective disorder. It hypothesizes that RUL LAP-ST will achieve a greater reduction in suicidal ideation while causing fewer cognitive side effects. Participants will be recruited from patients referred for ECT by their primary psychiatrists, ensuring that they meet clinical indications for the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 with major depressive disorder, bipolar disorder, or schizoaffective disorder who exhibit suicidal ideation.
Not a fit: Patients who are unstable or do not meet the clinical criteria for ECT may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients with suicidal ideation and treatment-resistant psychiatric disorders.
How similar studies have performed: Previous studies have indicated the effectiveness of ECT in treating suicidal ideation, but the specific approach of RUL LAP-ST is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Male or female patients 18 to 90 years of age 3. Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders 4. Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item 5. Use of effective method of birth control for women of child-bearing capacity 6. Patient is medically stable 7. No anticipated need to alter psychotropic medications for the duration of the study (except for urgent/emergent situations) 8. Ability of patient to fully participate in the informed consent process Exclusion Criteria: 1. Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment 2. Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding 3. 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 4. Implanted devices that make ECT unsafe 5. Clinical presentation of delirium or dementia 6. Active substance use disorders within 1 week of randomization 7. 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
Where this trial is running
Grand Rapids, Michigan
- Pine Rest Christian Mental Health Services — Grand Rapids, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Nagy A Youssef, MD, PhD — Pine Rest Christian Mental Health Services & Michigan State University
- Study coordinator: Nagy A Youssef, MD, PhD
- Email: nagy.youssef@pinerest.org
- Phone: 616-281-6451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.