NCT06529029 Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
| NCT ID | NCT06529029 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Michigan State University |
| Condition | Suicidal Ideation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-07-03 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Nagy A Youssef, MD, PhD
PRINCIPAL INVESTIGATOR
Pine Rest Christian Mental Health Services & Michigan State University
Frequently Asked Questions
Who can join the NCT06529029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Suicidal Ideation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06529029 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06529029 currently recruiting?
Yes, NCT06529029 is actively recruiting participants. Contact the research team at nagy.youssef@pinerest.org for enrollment information.
Where is the NCT06529029 trial being conducted?
This trial is being conducted at Grand Rapids, United States.
Who is sponsoring the NCT06529029 clinical trial?
NCT06529029 is sponsored by Michigan State University. The principal investigator is Nagy A Youssef, MD, PhD at Pine Rest Christian Mental Health Services & Michigan State University. The trial plans to enroll 30 participants.