RECRUITING

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

Talk to us

Conditions

Suicidal IdeationMajor Depressive DisorderSchizo Affective DisorderBipolar DisorderSuicideDepressionLow Amplitude Seizure TherapyElectroconvulsive TherapyNeuromodulationBrain Stimulation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-03
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06529029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Male or female patients 18 to 90 years of age
  3. 3. Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
  4. 4. Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item
  5. 5. Use of effective method of birth control for women of child-bearing capacity
  6. 6. Patient is medically stable
  7. 7. No anticipated need to alter psychotropic medications for the duration of the study (except for urgent/emergent situations)
  8. 8. Ability of patient to fully participate in the informed consent process
  1. 1. Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment
  2. 2. Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding
  3. 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. 4. Implanted devices that make ECT unsafe
  5. 5. Clinical presentation of delirium or dementia
  6. 6. Active substance use disorders within 1 week of randomization
  7. 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

Contacts and Locations

Study Contact

Nagy A Youssef, MD, PhD
CONTACT
616-281-6451
nagy.youssef@pinerest.org
Janelle M Kassien, LMSW
CONTACT
616-222-0324
janelle.kassien@pinerest.org

Principal Investigator

Nagy A Youssef, MD, PhD
PRINCIPAL_INVESTIGATOR
Pine Rest Christian Mental Health Services & Michigan State University

Study Locations (Sites)

Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
United States

Collaborators and Investigators

Sponsor: Michigan State University

  • Nagy A Youssef, MD, PhD, PRINCIPAL_INVESTIGATOR, Pine Rest Christian Mental Health Services & Michigan State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

  • Suicidal Ideation
  • Suicide
  • Depression
  • Major Depressive Disorder
  • Schizo Affective Disorder
  • Bipolar Disorder
  • Low Amplitude Seizure Therapy
  • Electroconvulsive Therapy
  • Neuromodulation
  • Brain Stimulation

Additional Relevant MeSH Terms

  • Suicidal Ideation
  • Major Depressive Disorder
  • Schizo Affective Disorder
  • Bipolar Disorder