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

ConditionsSuicidal Ideation Major Depressive Disorder Schizo Affective Disorder Bipolar Disorder

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-90

SponsorMichigan State University

About this trial

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

Qualifiers

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.

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

Disqualifiers

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 is deemed to affect cognition or safe ECT treatment

Implanted devices that make ECT unsafe

Trial design

Treatments tested in this trial

Sigma-Stim

Treatment groups

30 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Michigan State University

Lead sponsor

Pine Rest Christian Mental Health Services

Collaborator

Source ClinicalTrials.gov