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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
Michigan
Pine Rest Christian Mental Health Services
RECRUITING
Grand Rapids
Contact Information
Primary
Nagy A Youssef, MD, PhD
nagy.youssef@pinerest.org
616-281-6451
Backup
Janelle M Kassien, LMSW
janelle.kassien@pinerest.org
616-980-7516
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 30
Treatments
Experimental: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)
Low Amplitude Pulse Seizure Therapy RUL ECT at 600mA (or 700mA)
Active_comparator: RUL ECT (Electroconvulsive Therapy)
RUL Conventional pulse amplitude Electroconvulsive Therapy (ECT)
Related Therapeutic Areas
Sponsors
Collaborators: Pine Rest Christian Mental Health Services
Leads: Michigan State University

This content was sourced from clinicaltrials.gov