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Compares treatment options for Suicidal Ideation
Official title Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
ClinicalTrials.gov ID: NCT06529029
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Implanted devices that make ECT unsafe
- Clinical presentation of delirium or dementia
- Active substance use disorders within 1 week of randomization
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.