RightFit
RecruitingPhase 2 / Phase 3

Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy

Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a lower-strength electrical pulse treatment with standard electroconvulsive therapy (ECT). Both use electrical pulses on the right side of the head to cause a brief seizure. It is for adults ages 18 to 90 with depression and suicidal thoughts, and tests whether the lower-strength treatment reduces these thoughts better and causes fewer thinking or memory problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your psychiatrist has referred you for ECT because it is needed for your care.
  • You are 18 to 90 years old.
  • You currently have a major episode of depression with suicidal thoughts, linked to major depression, bipolar disorder, or schizoaffective disorder.
  • You score at least 2 on the suicidal thoughts question of the MADRS depression rating scale.
  • If you are a woman who can become pregnant, you use effective birth control.
  • Your physical health is stable.
  • You are not expected to need changes to your mental health medicines during the study, except in urgent situations.
  • You can fully take part in the process of understanding and agreeing to the study.

Who can't join

  • You have an unstable or serious health problem that greatly raises the risks of ECT or problems with thinking.
  • You are pregnant, plan to become pregnant during the study, or are breastfeeding.
  • You have a brain or nerve disorder judged to make ECT risky, metal in your head, or a brain injury or skull defect judged to affect thinking or ECT safety.
  • You have an implanted device that makes ECT unsafe.
  • You have delirium (sudden confusion) or dementia (lasting problems with memory and thinking).
  • You have had an active substance use disorder within 1 week before being assigned to a study group.
  • You had ECT in the past month, or a study doctor judges that a full course of ECT did not help you before.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MI