RecruitingNot ApplicableNCT05699226

Amplitude Titration to Improve ECT Clinical Outcomes

Amplitude Titration to Improve ECT Clinical Outcomes Randomized Clinical Trial


Sponsor

University of New Mexico

Enrollment

50 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT: H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2). H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adjusting the electrical dose (amplitude) used in electroconvulsive therapy (ECT) — a safe, effective treatment for severe depression — based on individual brain measurements leads to better outcomes and fewer side effects like memory problems. **You may be eligible if...** - You have major depressive disorder or bipolar II disorder - Your treatment team recommends ECT with right unilateral electrode placement **You may NOT be eligible if...** - You have a neurological condition such as traumatic brain injury, epilepsy, or Alzheimer's disease - You have schizophrenia or bipolar I disorder - You currently have a drug or alcohol use disorder (other than nicotine) - You have a medical reason you cannot have an MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESoterix Medical Incorporated 4x1 adapter

Device permits individualized amplitudes

DEVICETraditional ECT device

FDA approved ECT device with fixed amplitude.


Locations(1)

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

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NCT05699226


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